Trial Outcomes & Findings for High Flow Therapy for the Treatment of Respiratory Failure in the ED (NCT NCT02236559)
NCT ID: NCT02236559
Last Updated: 2019-05-23
Results Overview
Determine the efficacy of HFT compared to NIPPV in treating respiratory failure. The primary endpoint will be treatment failure within 72 hrs as determined by intubation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
204 participants
Primary outcome timeframe
Within 72 hrs
Results posted on
2019-05-23
Participant Flow
24 patients randomized but not enrolled were excluded for meeting exclusion criteria (10), consent not obtained or withdrawn (6), bedside clinician not comfortable with enrollment after randomization (2), \& patient identified to not need NiPPV after initial evaluation, thus failing to meet inclusion criteria (6). One patient met multiple criteria.
Participant milestones
| Measure |
Noninvasive Positive Pressure Ventilation
Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort.The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
116
|
|
Overall Study
COMPLETED
|
100
|
104
|
|
Overall Study
NOT COMPLETED
|
12
|
12
|
Reasons for withdrawal
| Measure |
Noninvasive Positive Pressure Ventilation
Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort.The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Overall Study
Met Exclusion
|
3
|
6
|
|
Overall Study
Did not Meet Inclusion
|
3
|
3
|
|
Overall Study
Subject Did Not Consent
|
4
|
2
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
High Flow Therapy for the Treatment of Respiratory Failure in the ED
Baseline characteristics by cohort
| Measure |
Noninvasive Positive Pressure Ventilation (NiPPV)
n=100 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of Noninvasive positive-pressure ventilation (NiPPV). NiPPV(Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation (HVNI)
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of High Velocity Nasal Insufflation (HVNI). HVNI (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
57 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
104 participants
n=7 Participants
|
204 participants
n=5 Participants
|
|
Presenting Condition
Asthma
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Presenting Condition
Congestive Heart Failure
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Presenting Condition
Chronic heart failure
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Presenting Condition
Chronic Obstructive Pulmonary Disorder (COPD)
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Presenting Condition
General dyspnea
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Discharge Diagnosis
Asthma
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Discharge Diagnosis
Acute decompensated heart failure
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Discharge Diagnosis
Acute COPD exacerbation
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Discharge Diagnosis
Acute hypercapnic respiratory failure
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Discharge Diagnosis
Acute hypoxic respiratory failure
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Discharge Diagnosis
Acute hypercapnic and hypoxic respiratory failure
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Discharge Diagnosis
Pneumonia/sepsis
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 72 hrsDetermine the efficacy of HFT compared to NIPPV in treating respiratory failure. The primary endpoint will be treatment failure within 72 hrs as determined by intubation.
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=100 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Treatment Failure Rate
Intubated at 72 Hours
|
13 Participants
|
7 Participants
|
|
Treatment Failure Rate
Not Intubated at 72 hours
|
87 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventialtion (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia.
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=100 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Ventilatory Indices 1
Heart Rate at Baseline
|
101 beats per min
Standard Deviation 21.3
|
100.4 beats per min
Standard Deviation 21.2
|
|
Ventilatory Indices 1
Heart Rate at 30 min
|
96.4 beats per min
Standard Deviation 22
|
95.6 beats per min
Standard Deviation 20.4
|
|
Ventilatory Indices 1
Heart Rate at 60 min
|
93.7 beats per min
Standard Deviation 20.4
|
94 beats per min
Standard Deviation 18.4
|
|
Ventilatory Indices 1
Heart Rate at 90 min
|
92.2 beats per min
Standard Deviation 21.6
|
91.8 beats per min
Standard Deviation 17.8
|
|
Ventilatory Indices 1
Heart Rate at 240 min
|
89.6 beats per min
Standard Deviation 18.2
|
9.21 beats per min
Standard Deviation 17.4
|
|
Ventilatory Indices 1
Heart Rate at Treatment Failure
|
108.9 beats per min
Standard Deviation 33.5
|
106.4 beats per min
Standard Deviation 29.8
|
SECONDARY outcome
Timeframe: At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and treatment failure if applicablePopulation: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Respiratory rate recorded at one and four hours, and at treatment failure if applicable.
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=100 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Ventilatory Indices 2
Respiratory Rate at Baseline
|
29.3 breaths per min
Standard Deviation 8.2
|
31.3 breaths per min
Standard Deviation 8.2
|
|
Ventilatory Indices 2
Respiratory Rate at 30 min
|
25.6 breaths per min
Standard Deviation 7.6
|
26.0 breaths per min
Standard Deviation 6.1
|
|
Ventilatory Indices 2
Respiratory Rate at 60 min
|
23.4 breaths per min
Standard Deviation 6.6
|
23.9 breaths per min
Standard Deviation 5.5
|
|
Ventilatory Indices 2
Respiratory Rate at 90 min
|
22.7 breaths per min
Standard Deviation 6.4
|
22.9 breaths per min
Standard Deviation 5.8
|
|
Ventilatory Indices 2
Respiratory Rate at 240 min
|
22.1 breaths per min
Standard Deviation 4.8
|
22.2 breaths per min
Standard Deviation 4.7
|
|
Ventilatory Indices 2
Respiratory Rate at Treatment Failure
|
27.4 breaths per min
Standard Deviation 10.2
|
26.4 breaths per min
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. SpO2 (a measurement of blood oxygen) recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=100 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Ventilatory Indices 3
SpO2 at Baseline
|
93.5 % SpO2
Standard Deviation 8.9
|
93.2 % SpO2
Standard Deviation 7
|
|
Ventilatory Indices 3
SpO2 at 30 min
|
97.8 % SpO2
Standard Deviation 3.3
|
97.5 % SpO2
Standard Deviation 3.4
|
|
Ventilatory Indices 3
SpO2 at 60 min
|
97.8 % SpO2
Standard Deviation 3
|
97.6 % SpO2
Standard Deviation 3
|
|
Ventilatory Indices 3
SpO2 at 90 min
|
97.7 % SpO2
Standard Deviation 2.3
|
97.8 % SpO2
Standard Deviation 2.3
|
|
Ventilatory Indices 3
SpO2 at 240 min
|
96.8 % SpO2
Standard Deviation 2.8
|
97.2 % SpO2
Standard Deviation 2.3
|
|
Ventilatory Indices 3
SpO2 at Treatment Failure
|
91.4 % SpO2
Standard Deviation 6.1
|
93.3 % SpO2
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol. Some participants were unable to give scores due to health status.
Evaluate the capability of HFT, compared to NIPPV, to affect indices of ventilation. Patient discomfort as rated on a VAS recorded at one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).. NOTE: Due to need for patients to be alert and provide this rating, the number analyzed is less than the total patients in the trial. VAS: Visual Analogue Scale. A Likert scale of facial expressions ranging from a smiley face to a frowning face used to assess the subjects' subjective level of dyspnea. Minimum 0 (no discomfort) to Maximum 5 (maximum discomfort).
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=100 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Ventilatory Indices 4
VAS at Baseline
|
4 score on a scale
Standard Deviation .5
|
4 score on a scale
Standard Deviation .5
|
|
Ventilatory Indices 4
VAS at 30 min
|
3 score on a scale
Standard Deviation 0.5
|
3 score on a scale
Standard Deviation 0.5
|
|
Ventilatory Indices 4
VAS at 60 min
|
2 score on a scale
Standard Deviation .5
|
2 score on a scale
Standard Deviation .5
|
|
Ventilatory Indices 4
VAS at 90 min
|
2 score on a scale
Standard Deviation 0.5
|
2 score on a scale
Standard Deviation 0.5
|
|
Ventilatory Indices 4
VAS at 240 min
|
2 score on a scale
Standard Deviation .5
|
2 score on a scale
Standard Deviation .4
|
|
Ventilatory Indices 4
VAS at Treatment Failure
|
4 score on a scale
Standard Deviation 3.5
|
3 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable)Population: If treatment failed prior to followup recording, subsequent data was not collected per the protocol. Some participants were unable to give scores due to health status.
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Modified Borg score recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable). NOTE: Due to the need for patients to be alert and able to provide this score, the number analyzed is less than the total patients in the trial. A modified Borg scale was used to ask the patient to describe their effort on a scale of 0 to 10, where 10 is extreme discomfort.
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=93 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=102 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Ventilatory Indices 5
Borg Score at Baseline
|
6.5 score on a scale
Standard Deviation 2.6
|
6.3 score on a scale
Standard Deviation 3
|
|
Ventilatory Indices 5
Borg Score at 30 min
|
4.3 score on a scale
Standard Deviation 2.7
|
4.3 score on a scale
Standard Deviation 2.7
|
|
Ventilatory Indices 5
Borg Score at 60 min
|
3.3 score on a scale
Standard Deviation 2.2
|
3.5 score on a scale
Standard Deviation 2.2
|
|
Ventilatory Indices 5
Borg Score at 90 min
|
2.9 score on a scale
Standard Deviation 2.2
|
3.3 score on a scale
Standard Deviation 2.1
|
|
Ventilatory Indices 5
Borg Score at 240 min
|
2.2 score on a scale
Standard Deviation 1.8
|
2.6 score on a scale
Standard Deviation 2
|
|
Ventilatory Indices 5
Borg Score at Treatment Failure
|
7.1 score on a scale
Standard Deviation 3
|
4.9 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: At one and four hoursPopulation: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (pH), a measurement of CO2 levels, recorded at one and four hours, and at treatment failure if applicable. NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=99 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Ventilatory Indices 6
pH at Baseline
|
7.33 pH
Standard Deviation .08
|
7.35 pH
Standard Deviation .1
|
|
Ventilatory Indices 6
pH at 60 min
|
7.34 pH
Standard Deviation .07
|
7.36 pH
Standard Deviation 0.08
|
|
Ventilatory Indices 6
pH at 240 min
|
7.36 pH
Standard Deviation .06
|
7.38 pH
Standard Deviation 0.07
|
|
Ventilatory Indices 6
pH at Treatment Failure
|
7.19 pH
Standard Deviation 0.04
|
7.25 pH
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: At one and four hoursPopulation: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (PCO2), a measure of CO2, recorded at one and four hours, and at treatment failure if applicable. NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=99 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Ventilatory Indices 7
PCO2 at Baseline
|
58.7 mmHg
Standard Deviation 25
|
53.4 mmHg
Standard Deviation 20.6
|
|
Ventilatory Indices 7
PCO2 at 60 min
|
55.2 mmHg
Standard Deviation 21.5
|
52.0 mmHg
Standard Deviation 19.6
|
|
Ventilatory Indices 7
PCO2 at 240 min
|
52.5 mmHg
Standard Deviation 17.8
|
46.3 mmHg
Standard Deviation 12.7
|
|
Ventilatory Indices 7
PCO2 at Treatment Failure
|
66.2 mmHg
Standard Deviation 33.3
|
69.2 mmHg
Standard Deviation 32.1
|
SECONDARY outcome
Timeframe: At one and four hoursPopulation: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (HCO3), a meausre of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable. NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=99 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Ventilatory Indices 8
HCO3 at Baseline
|
29.8 mEq/L
Standard Deviation 9.5
|
28.6 mEq/L
Standard Deviation 8.6
|
|
Ventilatory Indices 8
HCO3 at 60 min
|
29.4 mEq/L
Standard Deviation 9.5
|
28.4 mEq/L
Standard Deviation 8.4
|
|
Ventilatory Indices 8
HCO3 at 240 min
|
29.3 mEq/L
Standard Deviation 9.2
|
26.9 mEq/L
Standard Deviation 6.1
|
|
Ventilatory Indices 8
HCO3 at Treatment Failure
|
26.5 mEq/L
Standard Deviation 15.4
|
30.1 mEq/L
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: At one and four hoursPopulation: If treatment failed prior to followup recording, subsequent data was not collected per the protocol.
Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (base excess), a measure of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable. NOTE: Due to test error, the number analyzed is less than the total patients in the trial.
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=99 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Ventilatory Indices 9
Base excess at Baseline
|
2.87 mmol/L
Standard Deviation 7.76
|
2.35 mmol/L
Standard Deviation 8.12
|
|
Ventilatory Indices 9
Base excess at 60 min
|
2.71 mmol/L
Standard Deviation 7.92
|
2.3 mmol/L
Standard Deviation 7.95
|
|
Ventilatory Indices 9
Base excess at 240 min
|
3.14 mmol/L
Standard Deviation 7.79
|
1.47 mmol/L
Standard Deviation 5.48
|
|
Ventilatory Indices 9
Base excess at Treatment Failure
|
-2.12 mmol/L
Standard Deviation 13.75
|
2.29 mmol/L
Standard Deviation 12.88
|
SECONDARY outcome
Timeframe: Duration of hospital visitEvaluate the capability of HVNI, compared to NIPPV, to affect average length of stay.
Outcome measures
| Measure |
Noninvasive Positive Pressure Ventilation
n=100 Participants
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 Participants
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Length of Stay
|
6.0 days
Standard Deviation 4.4
|
6.8 days
Standard Deviation 5.7
|
Adverse Events
Noninvasive Positive Pressure Ventilation
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
High Velocity Nasal Insufflation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Noninvasive Positive Pressure Ventilation
n=100 participants at risk
Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV.Noninvasive positive-pressure ventilation (Respironics Vision V60; Philips Healthcare, Murrysville, PA) was initiated with an oronasal mask, with inspiratory and expiratory positive airway pressures (IPAP, EPAP) set at the lower end of the following settings and increased as necessary to alleviate respiratory distress: IPAP 10 to 20 cm H2O (or 5 to 15 cm H2O above EPAP), and EPAP 5 to 10 cm H2O. FiO2 was initiated at 1.0 for noninvasive positive-pressure ventilation. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
High Velocity Nasal Insufflation
n=104 participants at risk
Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. High-velocity nasal insufflation (Precision Flow; Vapotherm, Inc, Exeter, NH) (Figure 1) using a small-bore nasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort. The target for each intervention was to decrease breathing rate to fewer than 25 breaths/min and optimize comfort, whereas FiO2 was adjusted to maintain a pulse oximetry reading (SpO2) greater than 88%. The study model provided for having a respiratory therapist at bedside for the first 4 hours, which facilitated rapid changing of settings as needed.
|
|---|---|---|
|
Cardiac disorders
Death Outside Study Window
|
2.0%
2/100 • Number of events 2
|
0.00%
0/104
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Pratik Doshi, MD
McGovern Medical School at The University of Texas Health Science Center at Houston
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place