Trial Outcomes & Findings for Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence (NCT NCT04590014)
NCT ID: NCT04590014
Last Updated: 2024-03-20
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
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Through study completion, an average of 1.6 hours
Results posted on
2024-03-20
Participant Flow
Participant milestones
| Measure |
Conventional HVNI First New HVNI Second (Randomized)
Conventional First, New Second:
Patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
Next, patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
|
New HVNI First, Conventional HVNI Second (Randomized)
New First, Conventional Second:
Patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
Next, patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Conventional HVNI First New HVNI Second (Randomized)
Conventional First, New Second:
Patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
Next, patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
|
New HVNI First, Conventional HVNI Second (Randomized)
New First, Conventional Second:
Patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
Next, patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence
Baseline characteristics by cohort
| Measure |
Conventional HVNI First New HVNI Second (Randomized)
n=1 Participants
Conventional First, New Second:
Patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
Next, patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
|
New HVNI First, Conventional HVNI Second (Randomized)
n=3 Participants
New First, Conventional Second: Patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
Next, patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1.6 hoursPatient'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 |
Precision Flow
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow)Physiologic and ventilation parameters will be recorded.
|
HVT 2.0
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's new HVNI device design (HVT 2.0)Physiologic and ventilation parameters will be recorded.
|
|---|---|---|
|
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)
Baseline
|
2.5 Units on a scale
Interval 0.98 to 4.02
|
3 Units on a scale
Interval 0.61 to 5.38
|
|
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)
Therapeutic Characterization once the HVNI settings are having a therapeutic effect.
|
2.5 Units on a scale
Interval 0.25 to 4.75
|
2 Units on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1.6 hoursHeart rate, measured in beats per minute (bpm)
Outcome measures
| Measure |
Precision Flow
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow)Physiologic and ventilation parameters will be recorded.
|
HVT 2.0
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's new HVNI device design (HVT 2.0)Physiologic and ventilation parameters will be recorded.
|
|---|---|---|
|
Patient Vital Signs - Heart Rate [HR]
Baseline
|
81 bpm
Interval 78.24 to 83.76
|
76.5 bpm
Interval 72.32 to 80.68
|
|
Patient Vital Signs - Heart Rate [HR]
Therapeutic Characterization once the HVNI settings are having a therapeutic effect.
|
81.5 bpm
Interval 79.98 to 83.02
|
79 bpm
Interval 75.47 to 82.53
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1.6 hoursRespiratory rate, measured in breaths per minute (brpm)
Outcome measures
| Measure |
Precision Flow
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow)Physiologic and ventilation parameters will be recorded.
|
HVT 2.0
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's new HVNI device design (HVT 2.0)Physiologic and ventilation parameters will be recorded.
|
|---|---|---|
|
Patient Vital Signs - Respiratory Rate [RR]
Baseline
|
19 breaths per min
Interval 11.42 to 26.58
|
17 breaths per min
Interval 12.89 to 21.11
|
|
Patient Vital Signs - Respiratory Rate [RR]
Therapeutic Characterization once the HVNI settings are having a therapeutic effect.
|
16 breaths per min
Interval 8.94 to 23.06
|
12 breaths per min
Interval 6.49 to 17.51
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1.6 hoursBlood pressure (systolic) measured in mmHg
Outcome measures
| Measure |
Precision Flow
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow)Physiologic and ventilation parameters will be recorded.
|
HVT 2.0
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's new HVNI device design (HVT 2.0)Physiologic and ventilation parameters will be recorded.
|
|---|---|---|
|
Patient Vital Signs - Blood Pressure [BP]
Baseline Systolic
|
126.5 mmHg
Interval 108.07 to 144.98
|
125 mmHg
Interval 90.87 to 159.13
|
|
Patient Vital Signs - Blood Pressure [BP]
Baseline Diastolic
|
63 mmHg
Interval 47.09 to 78.91
|
68.5 mmHg
Interval 53.61 to 83.29
|
|
Patient Vital Signs - Blood Pressure [BP]
Therapeutic Systolic
|
129 mmHg
Interval 111.7 to 146.3
|
136 mmHg
Interval 104.46 to 166.54
|
|
Patient Vital Signs - Blood Pressure [BP]
Therapeutic Diastolic
|
73.5 mmHg
Interval 55.15 to 91.85
|
68.5 mmHg
Interval 57.84 to 79.16
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1.6 hoursSpO2 measured as percentage of oxygen saturation (%)
Outcome measures
| Measure |
Precision Flow
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow)Physiologic and ventilation parameters will be recorded.
|
HVT 2.0
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's new HVNI device design (HVT 2.0)Physiologic and ventilation parameters will be recorded.
|
|---|---|---|
|
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
Baseline
|
96 % oxygen
Interval 94.0 to 98.0
|
95 % oxygen
Interval 88.85 to 101.15
|
|
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
Therapeutic Characterization once the HVNI settings are having a therapeutic effect.
|
94.5 % oxygen
Interval 93.58 to 95.42
|
94.5 % oxygen
Interval 90.71 to 98.29
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1.6 hoursTcPCO2, measured as percentage of CO2 (%)
Outcome measures
| Measure |
Precision Flow
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow)Physiologic and ventilation parameters will be recorded.
|
HVT 2.0
n=4 Participants
Patients were placed on HVNI therapy using Vapotherm's new HVNI device design (HVT 2.0)Physiologic and ventilation parameters will be recorded.
|
|---|---|---|
|
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
Baseline
|
52.1 % CO2
Interval 30.03 to 74.17
|
54.8 % CO2
Interval 42.3 to 67.31
|
|
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
Therapeutic Characterization once the HVNI settings are having a therapeutic effect.
|
49.9 % CO2
Interval 15.14 to 84.66
|
53.1 % CO2
Interval 41.36 to 64.84
|
Adverse Events
Precision Flow
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HVT 2.0
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