Trial Outcomes & Findings for Clinical Stabilization of Hypercapnia: NIPPV v HVNI (NCT NCT04709562)
NCT ID: NCT04709562
Last Updated: 2024-08-09
Results Overview
Patient's subjective assessment of their dyspnea, rated as a modified Borg score on a scale from 0 to 10. Higher scores indicate a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 min
Results posted on
2024-08-09
Participant Flow
Participant milestones
| Measure |
High Velocity Nasal Insufflation (HVNI)
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
32
|
|
Overall Study
COMPLETED
|
36
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Stabilization of Hypercapnia: NIPPV v HVNI
Baseline characteristics by cohort
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 Years old
STANDARD_DEVIATION 11.18 • n=5 Participants
|
67.7 Years old
STANDARD_DEVIATION 9.44 • n=7 Participants
|
65.96 Years old
STANDARD_DEVIATION 10.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
32 participants
n=7 Participants
|
68 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 minPopulation: The participants had to have an RPD reading at all four time points.
Patient's subjective assessment of their dyspnea, rated as a modified Borg score on a scale from 0 to 10. Higher scores indicate a worse outcome.
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Rated Perceived Dyspnea [RPD]
Baseline
|
5.4 units on a scale (0-10)
Standard Deviation 2.93
|
5.6 units on a scale (0-10)
Standard Deviation 2.41
|
|
Rated Perceived Dyspnea [RPD]
30 Min
|
3.97 units on a scale (0-10)
Standard Deviation 2.82
|
4.54 units on a scale (0-10)
Standard Deviation 1.65
|
|
Rated Perceived Dyspnea [RPD]
60 Min
|
3.09 units on a scale (0-10)
Standard Deviation 2.70
|
4.07 units on a scale (0-10)
Standard Deviation 1.77
|
|
Rated Perceived Dyspnea [RPD]
240 Min
|
3.17 units on a scale (0-10)
Standard Deviation 2.59
|
3.34 units on a scale (0-10)
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: During four time points in the study; Baseline, 30 min, 60 min, and 240 minPopulation: Patients who had their Heart Rate collected during the four time points in the study.
Heart rate, measured in beats per minute (bpm)
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Vital Signs - Heart Rate [HR]
Baseline
|
93.2 BPM
Standard Deviation 17.37
|
85.9 BPM
Standard Deviation 16.58
|
|
Patient Vital Signs - Heart Rate [HR]
30 min
|
90.78 BPM
Standard Deviation 15.50
|
87.24 BPM
Standard Deviation 21.02
|
|
Patient Vital Signs - Heart Rate [HR]
60 min
|
90.03 BPM
Standard Deviation 14.25
|
84.04 BPM
Standard Deviation 14.34
|
|
Patient Vital Signs - Heart Rate [HR]
240 min
|
91.22 BPM
Standard Deviation 14.45
|
82.40 BPM
Standard Deviation 17.92
|
SECONDARY outcome
Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 minPopulation: Patients who had their Respiratory Rate collected during the four different timepoints in the study.
Respiratory rate, measured in breaths per minute (brpm)
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Vital Signs - Respiratory Rate [RR]
Baseline
|
20.9 Breaths per min
Standard Deviation 5.00
|
21.2 Breaths per min
Standard Deviation 6.09
|
|
Patient Vital Signs - Respiratory Rate [RR]
30 min
|
21.13 Breaths per min
Standard Deviation 6.41
|
22.12 Breaths per min
Standard Deviation 6.90
|
|
Patient Vital Signs - Respiratory Rate [RR]
60 min
|
20.56 Breaths per min
Standard Deviation 5.30
|
21.32 Breaths per min
Standard Deviation 7.05
|
|
Patient Vital Signs - Respiratory Rate [RR]
240 min
|
20.97 Breaths per min
Standard Deviation 4.82
|
20.92 Breaths per min
Standard Deviation 6.30
|
SECONDARY outcome
Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 minPopulation: Patients who had their SPO2 collected during the four timepoints in the study.
SpO2 measured as percentage of oxygen saturation (%)
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Vital Signs - Oxygen Saturation [SpO2]
Baseline
|
94.4 percentage of oxygen saturation
Standard Deviation 7.42
|
96.8 percentage of oxygen saturation
Standard Deviation 3.37
|
|
Patient Vital Signs - Oxygen Saturation [SpO2]
30 min
|
95.69 percentage of oxygen saturation
Standard Deviation 3.46
|
96.80 percentage of oxygen saturation
Standard Deviation 3.89
|
|
Patient Vital Signs - Oxygen Saturation [SpO2]
60 min
|
95.78 percentage of oxygen saturation
Standard Deviation 3.08
|
97.28 percentage of oxygen saturation
Standard Deviation 3.29
|
|
Patient Vital Signs - Oxygen Saturation [SpO2]
240 min
|
95.56 percentage of oxygen saturation
Standard Deviation 2.91
|
97.16 percentage of oxygen saturation
Standard Deviation 3.44
|
SECONDARY outcome
Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 minPopulation: Patients that had the Stability Index collected during the four time points in the study.
Patient stability index, measured by patient's ability to speak in full sentences, rated on a 0-100 scale. Higher scores indicate a better outcome.
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Communication Capability - Patient Stability Index
Baseline
|
62.00 units on a scale (0-100)
Standard Deviation 28.00
|
62.50 units on a scale (0-100)
Standard Deviation 23.09
|
|
Patient Communication Capability - Patient Stability Index
30 min
|
73.81 units on a scale (0-100)
Standard Deviation 18.79
|
68.92 units on a scale (0-100)
Standard Deviation 17.23
|
|
Patient Communication Capability - Patient Stability Index
60 min
|
77.75 units on a scale (0-100)
Standard Deviation 17.97
|
76.48 units on a scale (0-100)
Standard Deviation 15.78
|
|
Patient Communication Capability - Patient Stability Index
240 min
|
82.28 units on a scale (0-100)
Standard Deviation 17.67
|
82.00 units on a scale (0-100)
Standard Deviation 19.37
|
SECONDARY outcome
Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 minPopulation: Patients that had this lab value collected during the four time points in the study.
pH, measured as units on a pH scale from 0 - 14. Neutral scores indicate a better outcome.
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Venous Blood Gas - pH
Baseline
|
7.27 pH
Standard Deviation .06
|
7.27 pH
Standard Deviation .04
|
|
Patient Venous Blood Gas - pH
30 min
|
7.3 pH
Standard Deviation .06
|
7.28 pH
Standard Deviation 0.06
|
|
Patient Venous Blood Gas - pH
60 min
|
7.31 pH
Standard Deviation 0.06
|
7.3 pH
Standard Deviation 0.07
|
|
Patient Venous Blood Gas - pH
240 min
|
7.31 pH
Standard Deviation 0.06
|
7.31 pH
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 minPopulation: Patients that had PCO2 collected during the four time points during the study.
Partial pressure of CO2 (PCO2), measured in mmHg
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Venous Blood Gas - Venous PCO2
Baseline
|
77.8 mmHg
Standard Deviation 13.6
|
76.5 mmHg
Standard Deviation 13.6
|
|
Patient Venous Blood Gas - Venous PCO2
30 min
|
72.56 mmHg
Standard Deviation 15.71
|
73.22 mmHg
Standard Deviation 19.04
|
|
Patient Venous Blood Gas - Venous PCO2
60 min
|
71.19 mmHg
Standard Deviation 14.85
|
70.95 mmHg
Standard Deviation 19.56
|
|
Patient Venous Blood Gas - Venous PCO2
240 min
|
68.76 mmHg
Standard Deviation 13.68
|
67.29 mmHg
Standard Deviation 20.03
|
SECONDARY outcome
Timeframe: Baseline, at study start onlySodium \[Na+\], measured in mEq/L
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Basic Metabolic Panel - Sodium
|
139.9 mEq/L
Standard Deviation 3.5
|
140.4 mEq/L
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline, at study start onlyPotassium \[K+\], measured in mEq/L
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Basic Metabolic Panel - Potassium
|
4.4 mEq/L
Standard Deviation .63
|
4.4 mEq/L
Standard Deviation .66
|
SECONDARY outcome
Timeframe: Baseline, at study start onlyChloride \[Cl-\], measured in mEq/L
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Basic Metabolic Panel - Chloride
|
97.7 mEq/L
Standard Deviation 6.4
|
99.9 mEq/L
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline, at study start onlyLactate, measured in mEq/L
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Basic Metabolic Panel - Lactate
|
1.6 mEq/L
Standard Deviation 1.25
|
1.2 mEq/L
Standard Deviation .84
|
SECONDARY outcome
Timeframe: Baseline, at study start onlyGlucose, measured in mg/dL
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Basic Metabolic Panel - Glucose
|
133.8 mg/dL
Standard Deviation 54.83
|
137.2 mg/dL
Standard Deviation 40.03
|
SECONDARY outcome
Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 minPopulation: Patients that had this lab value collected at the timepoints during the study.
Base Excess, measured in mEq/L
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=23 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=23 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Base Excess - Base Excess
Baseline
|
6.7 mEq/L
Standard Deviation 4.91
|
7.7 mEq/L
Standard Deviation 5.56
|
|
Patient Base Excess - Base Excess
30 min
|
7.43 mEq/L
Standard Deviation 4.52
|
7.74 mEq/L
Standard Deviation 7.03
|
|
Patient Base Excess - Base Excess
60 min
|
6.71 mEq/L
Standard Deviation 4.50
|
7.48 mEq/L
Standard Deviation 6.45
|
|
Patient Base Excess - Base Excess
240 min
|
5.97 mEq/L
Standard Deviation 5.50
|
6.39 mEq/L
Standard Deviation 6.74
|
SECONDARY outcome
Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 minPopulation: Patients that had this lab value collected during the four time points in the study.
Bicarbonate, measured in mEq/L
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=33 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Bicarbonate - Bicarbonate
Baseline
|
32.0 mEq/L
Standard Deviation 7.63
|
33.8 mEq/L
Standard Deviation 6.60
|
|
Patient Bicarbonate - Bicarbonate
30 min
|
33.18 mEq/L
Standard Deviation 5.61
|
32.43 mEq/L
Standard Deviation 9.86
|
|
Patient Bicarbonate - Bicarbonate
60 min
|
32.75 mEq/L
Standard Deviation 5.69
|
32.45 mEq/L
Standard Deviation 8.11
|
|
Patient Bicarbonate - Bicarbonate
240 min
|
30.93 mEq/L
Standard Deviation 8.73
|
32.18 mEq/L
Standard Deviation 7.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 minPopulation: Patients that had this data collected at the four time points during the study.
Patient's subjective assessment of relief of their symptoms while on therapy, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Perception Score - Relief of Symptoms
Baseline
|
34.8 units on a scale
Standard Deviation 24.81
|
38.5 units on a scale
Standard Deviation 22.19
|
|
Patient Perception Score - Relief of Symptoms
30 min
|
28.45 units on a scale
Standard Deviation 22.26
|
38.05 units on a scale
Standard Deviation 19.91
|
|
Patient Perception Score - Relief of Symptoms
60 min
|
24.68 units on a scale
Standard Deviation 19.86
|
27.82 units on a scale
Standard Deviation 20.10
|
|
Patient Perception Score - Relief of Symptoms
240 min
|
28.48 units on a scale
Standard Deviation 24.09
|
24.58 units on a scale
Standard Deviation 21.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During four time points in the study over the course of four hours; Baseline, 30 min, 60 min, and 240 minPopulation: Patients who had their score collected during the four different timepoints in the study.
Patient's subjective assessment of their comfort and tolerance of therapy during the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=36 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=32 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Patient Perception Score - Comfort/Tolerance
60 min
|
22.35 units on a scale
Standard Deviation 19.49
|
42.41 units on a scale
Standard Deviation 28.30
|
|
Patient Perception Score - Comfort/Tolerance
Baseline
|
34.8 units on a scale
Standard Deviation 24.81
|
38.5 units on a scale
Standard Deviation 22.19
|
|
Patient Perception Score - Comfort/Tolerance
30 min
|
28.39 units on a scale
Standard Deviation 22.53
|
44.82 units on a scale
Standard Deviation 24.41
|
|
Patient Perception Score - Comfort/Tolerance
240 min
|
20.13 units on a scale
Standard Deviation 23.45
|
43.25 units on a scale
Standard Deviation 32.02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study end, 4 hours from study startClinician's subjective assessment of the expected and perceived patient outcomes as a result of therapy following testing, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=31 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=25 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Clinician Perception Score - Expected/Perceived Outcomes
|
23.26 units on a scale
Standard Deviation 14.33
|
16.32 units on a scale
Standard Deviation 14.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study end, 4 hours from study startClinician's subjective assessment of the patient's comfort and tolerance of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=31 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=25 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Clinician Perception Score - Patient Comfort/Tolerance
|
17.58 units on a scale
Standard Deviation 13.61
|
22.04 units on a scale
Standard Deviation 20.87
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At study end, 4 hours from study startClinician's subjective assessment of the ease of use of therapy during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Outcome measures
| Measure |
High Velocity Nasal Insufflation (HVNI)
n=31 Participants
Patients randomly assigned to this arm will be placed on HVNI therapy with an appropriately fitted Vapotherm Prosoft HVNI nasal cannula. Physiologic and ventilation parameters will be recorded.
High Velocity Nasal Insufflation (HVNI): The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
Noninvasive Positive Pressure Ventilation (NIPPV)
n=25 Participants
Patients randomly assigned to this arm will be placed on NIPPV therapy with an appropriately fitted full face mask using a pressure support mechanical ventilator system. Physiologic and ventilation parameters will be recorded.
Noninvasive Positive Pressure Ventilation (NIPPV): The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
|
|---|---|---|
|
Clinician Perception Score - Ease of Use
|
16.45 units on a scale
Standard Deviation 16.25
|
15.08 units on a scale
Standard Deviation 18.68
|
Adverse Events
High Velocity Nasal Insufflation (HVNI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Noninvasive Positive Pressure Ventilation (NIPPV)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place