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HVNI Ambulation Feasibility Study

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ClinicalTrials.gov Identifier: NCT03885726
Recruitment Status : Completed
First Posted : March 22, 2019
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Knox Community Hospital
Riverside Regional Medical Center
Midwest Chest Consultants
Information provided by (Responsible Party):
Vapotherm, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Respiratory Insufficiency
Dyspnea
Interventions Device: Precision Flow Plus
Device: Treatment as Usual
Enrollment 32
Recruitment Details Recruitment for this study took place in both an inpatient hospital setting and an outpatient medical clinic setting.
Pre-assignment Details Of the N=32 enrolled patients, only N=28 completed both study arms. An additional N=3 patients were excluded from study analysis, making the total number of patient data analyzed post-hoc N=25.
Arm/Group Title All Study Participants
Hide Arm/Group Description Crossover study design with the first intervention as "Treatment as Usual - 6 minute walk test" (TAU), followed by an adequate recovery period. The second intervention was "High Velocity Nasal Insufflation - 6 minute walk test" (HVNI). The patient population for both treatment arms was represented by both inpatients and outpatients.
Period Title: Overall Study
Started 32
Completed 28
Not Completed 4
Reason Not Completed
Staffing issues/lost interest             1
Early discharge from hospital             3
Arm/Group Title All Study Participants
Hide Arm/Group Description Crossover study design with the first intervention as "Treatment as Usual - 6 minute walk test" (TAU), followed by an adequate recovery period. The second intervention was "High Velocity Nasal Insufflation - 6 minute walk test" (HVNI). The patient population for both treatment arms was represented by both inpatients and outpatients.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 25 participants
66
(58 to 68.3)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
12
  48.0%
Male
13
  52.0%
[1]
Measure Analysis Population Description: Out of the N=28 patients who completed both arms of the study, N=3 were excluded post-hoc, making the total analysis population N=25.
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
[1]
Measure Analysis Population Description: N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc.
1.Primary Outcome
Title Exercise Performance- Distance
Hide Description Defined as the distance of patient ambulation
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: meters
78.8
(63 to 144.1)
88.6
(75.3 to 172.6)
182.9
(134.1 to 453.4)
165.2
(136.9 to 455.2)
2.Primary Outcome
Title Exercise Performance- Duration
Hide Description Defined as the duration of patient ambulation
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: seconds
211.5
(139.5 to 376.5)
229.5
(164.3 to 387)
307
(192.5 to 452.5)
250
(180 to 537)
3.Secondary Outcome
Title Patient Recovery Interval
Hide Description Defined as recovery time (return time to baseline rated perceived dyspnea).
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
N=32 patients were enrolled in the study; of those, N=28 completed both study arms. A total of N=25 were analyzed post-hoc.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: seconds
283.5
(232 to 462.3)
191.5
(172 to 395.5)
239
(143 to 330)
245
(135.5 to 359.5)
4.Secondary Outcome
Title Patient Vital Signs - Blood Pressure
Hide Description Patient blood pressure (systolic) measured in mmHg
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: mmHg
125.5
(119.8 to 152.5)
137
(114.8 to 141.5)
129
(120 to 132)
113
(110 to 120)
5.Secondary Outcome
Title Patient Vital Signs-- Heart Rate [HR]
Hide Description Heart rate in bpm
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: beats per minute (bpm)
101
(88.3 to 108.3)
94
(89.8 to 103.5)
81
(72 to 89)
79
(75 to 82)
6.Secondary Outcome
Title Patient Vital Signs-- Respiratory Rate [RR]
Hide Description Respiratory rate in breaths per minute
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: breaths per minute (brpm)
20
(17.5 to 20)
18
(17.5 to 20)
20
(18 to 20)
20
(18 to 20)
7.Secondary Outcome
Title Patient Vital Signs-- Arterial Oxygen Saturation
Hide Description SpO2 measured as percentage of oxygen saturation (%).
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: percentage of oxygen saturation (%)
95
(93 to 97.3)
95
(93 to 98)
95
(94 to 95)
95
(93 to 97)
8.Secondary Outcome
Title Patient Vital Signs-- Rated Perceived Exertion (RPE)
Hide Description Patient's subjective assessment of their exertion, rated as a modified Borg score on a scale from 0 to 10 . Higher scores indicate a worse outcome.
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
1.5
(0 to 3)
0.5
(0 to 1.25)
0
(0 to 0.5)
0.5
(0 to 0.5)
9.Secondary Outcome
Title Patient Vital Signs-- Rated Perceived Dyspnea (RPD)
Hide Description 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.
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0.5
(0 to 2)
0.75
(0 to 1)
0
(0 to 0.5)
0
(0 to 0)
10.Secondary Outcome
Title Clinician Perception Score- Patient Response to Therapy
Hide Description Clinician's subjective assessment of the patient's clinical response to the therapy, rated as units on a visual analog scale from 0 to 100. A lower score indicates a better outcome.
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
44.5
(3.38 to 69.5)
8.25
(1.13 to 61.5)
9
(3 to 49.5)
37.5
(15 to 58.5)
11.Secondary Outcome
Title Clinician Perception Score- Patient Tolerance and Comfort
Hide Description Clinician's subjective assessment of the patient's comfort on and tolerance of the therapy, rated as units on a visual analog scale from 0 to 100. Lower values indicate a better outcome.
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
33.8
(1.75 to 69.3)
4
(1.25 to 17.1)
1
(0 to 20.5)
19
(8.5 to 82)
12.Secondary Outcome
Title Clinician Perception Score- Frequency of Technical/Clinical Difficulties
Hide Description 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.
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1.5
(1 to 4.5)
1.5
(0.5 to 6.38)
1
(0 to 2.5)
3
(0.5 to 17.5)
13.Secondary Outcome
Title Clinician Perception Score- Simplicity of Set-up and Use
Hide Description Clinician's subjective assessment of the the simplicity of setting up and using the equipment, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of the N=32 patients enrolled in the study, N=28 completed all study arms. An additional N=3 were excluded from post-hoc analysis, making the final analysis N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
1
(0.25 to 2.25)
1.5
(0 to 2.5)
1
(0.5 to 2.75)
2
(0.75 to 3)
14.Secondary Outcome
Title Clinician Perception Score- Support/Adjustment Required
Hide Description Clinician's subjective assessment of the amount of support and adjustment required from the clinician during the test, rated as units on a visual analog scale from 0 to 100. Lower scores indicate a better outcome.
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 13 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2
(0.25 to 11.3)
2
(0.5 to 20.3)
18.5
(1 to 33.8)
18.5
(0.5 to 48.3)
15.Secondary Outcome
Title Patient Vital Signs - Blood Pressure
Hide Description Patient blood pressure (diastolic) measured in mmHg
Time Frame Through study completion, an average of 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Of N=32 enrolled patients, N=28 completed both study arms, and N=3 were excluded post-hoc, making the analyzed population N=25.
Arm/Group Title Treatment as Usual (Inpatient) High Velocity Nasal Insufflation (Inpatient) Treatment as Usual (Outpatient) High Velocity Nasal Insufflation (Outpatient)
Hide Arm/Group Description:
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Treatment as Usual: Conventional therapy per institution
Precision Flow Plus: High Velocity Nasal Insufflation
Overall Number of Participants Analyzed 16 16 9 9
Median (Inter-Quartile Range)
Unit of Measure: mmHg
2
(0.25 to 11.3)
2
(0.5 to 20.3)
18.5
(1 to 33.8)
18.5
(0.5 to 48.3)
Time Frame 8 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment as Usual High Velocity Nasal Insufflation
Hide Arm/Group Description Treatment as Usual: Conventional therapy per institution Precision Flow Plus: High velocity nasal insufflation
All-Cause Mortality
Treatment as Usual High Velocity Nasal Insufflation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Hide Serious Adverse Events
Treatment as Usual High Velocity Nasal Insufflation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment as Usual High Velocity Nasal Insufflation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: George C. Dungan, II
Organization: Vapotherm, Inc.
Phone: (267)347-3305
EMail: gdungan@vtherm.com
Layout table for additonal information
Responsible Party: Vapotherm, Inc.
ClinicalTrials.gov Identifier: NCT03885726    
Other Study ID Numbers: RP-VTPF2018001Sci
First Submitted: February 25, 2019
First Posted: March 22, 2019
Results First Submitted: September 2, 2020
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020