Trial Outcomes & Findings for Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs (NCT NCT04512781)
NCT ID: NCT04512781
Last Updated: 2024-02-23
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
26 participants
Primary outcome timeframe
This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)
Results posted on
2024-02-23
Participant Flow
Participant milestones
| Measure |
Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula
Conventional Legacy Cannula Design (Control) first for 40 min, then Prosoft Cannula for 40min - then Unicorn Cannula for 40 min")
|
Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula
Conventional Legacy Cannula Design (Control) first for 40 min, then Unicorn Cannula for 40min - then Prosoft Cannula for 40 min")
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
11
|
|
Overall Study
COMPLETED
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Cannulae Designs
Baseline characteristics by cohort
| Measure |
Conventional Legacy Cannula Design (Control) - Prosoft Cannula - Unicorn Cannula
n=15 Participants
During this session, patients will be placed on HVNI therapy with an appropriately fitted Vapotherm conventional legacy cannula. Physiologic and ventilation parameters were recorded.
Patients were assigned to go on the Prosoft Cannula second. Physiologic and ventilation parameters were recorded.
Patients were assigned to go on the Unicorn Cannula third. Physiologic and ventilation parameters were recorded
|
Conventional Legacy Cannula Design (Control) - Unicorn Cannula - Prosoft Cannula
n=11 Participants
During this session, patients will be placed on HVNI therapy with an appropriately fitted Vapotherm conventional legacy cannula. Physiologic and ventilation parameters were recorded.
Patients were assigned to go on the Unicorn Cannula second. Physiologic and ventilation parameters were recorded.
Patients were assigned to go on the Prosoft Cannula third. Physiologic and ventilation parameters were recorded.
|
Total
n=26 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 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
|
|
height
|
1.78 m
n=5 Participants
|
1.72 m
n=7 Participants
|
1.77 m
n=5 Participants
|
|
Weight
|
108.8 kg
n=5 Participants
|
86.18 kg
n=7 Participants
|
91 kg
n=5 Participants
|
PRIMARY outcome
Timeframe: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)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 |
Legacy Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Legacy Cannula. Physiologic and ventilation parameters were recorded.
|
Prosoft Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Prosoft Cannula. Physiologic and ventilation parameters were recorded.
|
Unicorn Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Unicorn Cannula. Physiologic and ventilation parameters were recorded.
|
|---|---|---|---|
|
Patient Vital Signs -- Rated Perceived Dyspnea (RPD)
|
3 units on a scale
Interval 3.0 to 3.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
2.5 units on a scale
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)Heart Rate (HR) The number of beats per minute.
Outcome measures
| Measure |
Legacy Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Legacy Cannula. Physiologic and ventilation parameters were recorded.
|
Prosoft Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Prosoft Cannula. Physiologic and ventilation parameters were recorded.
|
Unicorn Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Unicorn Cannula. Physiologic and ventilation parameters were recorded.
|
|---|---|---|---|
|
Patient Vital Signs - Heart Rate [HR]
|
78 Beats per minute
Interval 73.0 to 85.0
|
74 Beats per minute
Interval 71.0 to 79.0
|
76 Beats per minute
Interval 69.0 to 80.0
|
SECONDARY outcome
Timeframe: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)Respiratory rate, measured in breaths per minute (brpm)
Outcome measures
| Measure |
Legacy Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Legacy Cannula. Physiologic and ventilation parameters were recorded.
|
Prosoft Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Prosoft Cannula. Physiologic and ventilation parameters were recorded.
|
Unicorn Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Unicorn Cannula. Physiologic and ventilation parameters were recorded.
|
|---|---|---|---|
|
Patient Vital Signs - Respiratory Rate [RR]
|
16 BRPM
Interval 15.0 to 20.0
|
18 BRPM
Interval 14.0 to 20.0
|
16 BRPM
Interval 14.0 to 19.0
|
SECONDARY outcome
Timeframe: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)Blood pressure (systolic) measured in mmHg
Outcome measures
| Measure |
Legacy Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Legacy Cannula. Physiologic and ventilation parameters were recorded.
|
Prosoft Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Prosoft Cannula. Physiologic and ventilation parameters were recorded.
|
Unicorn Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Unicorn Cannula. Physiologic and ventilation parameters were recorded.
|
|---|---|---|---|
|
Patient Vital Signs - Blood Pressure [BP]
Systolic
|
126 mmHg
Interval 119.25 to 132.75
|
126 mmHg
Interval 119.52 to 132.48
|
123 mmHg
Interval 114.62 to 131.38
|
|
Patient Vital Signs - Blood Pressure [BP]
Diastolic
|
71 mmHg
Interval 66.41 to 75.6
|
71 mmHg
Interval 66.75 to 75.25
|
69 mmHg
Interval 64.8 to 73.2
|
SECONDARY outcome
Timeframe: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)SpO2 measured as percentage of oxygen saturation (%)
Outcome measures
| Measure |
Legacy Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Legacy Cannula. Physiologic and ventilation parameters were recorded.
|
Prosoft Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Prosoft Cannula. Physiologic and ventilation parameters were recorded.
|
Unicorn Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Unicorn Cannula. Physiologic and ventilation parameters were recorded.
|
|---|---|---|---|
|
Patient Vital Signs - Arterial Oxygen Saturation [SpO2]
|
95 percentage of oxygen saturation
Interval 93.0 to 97.0
|
95 percentage of oxygen saturation
Interval 93.0 to 96.0
|
95 percentage of oxygen saturation
Interval 93.0 to 96.0
|
SECONDARY outcome
Timeframe: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)TcPCO2 measured as percentage of CO2 (%)
Outcome measures
| Measure |
Legacy Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Legacy Cannula. Physiologic and ventilation parameters were recorded.
|
Prosoft Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Prosoft Cannula. Physiologic and ventilation parameters were recorded.
|
Unicorn Cannula
n=26 Participants
During this session, participants completed the entire study intervention while wearing the Unicorn Cannula. Physiologic and ventilation parameters were recorded.
|
|---|---|---|---|
|
Patient Vital Signs - Transcutaneous CO2 [TcPCO2]
|
53.8 percentage of CO2
Interval 46.0 to 60.0
|
50.7 percentage of CO2
Interval 46.0 to 57.0
|
50.3 percentage of CO2
Interval 45.0 to 56.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: This was collected at the end of each phase, for a total of three phases over the course of the study (2 hours 15 min)Clinician's subjective assessment of the frequency of technical or clinical issues during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 3 hoursClinician'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
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 3 hoursClinician'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
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 3 hoursClinician's subjective assessment of the level of monitoring and support for therapy required during the the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 3 hoursClinician'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
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 3 hoursPatient'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
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completion, an average of 3 hoursPatient's subjective assessment of their 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
Outcome data not reported
Adverse Events
Legacy Cannula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prosoft Cannula
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unicorn Cannula
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