HVNI Ambulation Feasibility Study

• 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: Vapotherm, Inc.
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		All Study Participants
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
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.

Outcome Measures

1. Primary Outcome

Title	Exercise Performance- Distance
Description	Defined as the distance of patient ambulation
Time Frame	Through study completion, an average of 1 day

Outcome Measure Data

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)
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
Description	Defined as the duration of patient ambulation
Time Frame	Through study completion, an average of 1 day

Outcome Measure Data

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)
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
Description	Defined as recovery time (return time to baseline rated perceived dyspnea).
Time Frame	Through study completion, an average of 1 day

Outcome Measure Data

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)
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
Description	Patient blood pressure (systolic) measured in mmHg
Time Frame	Through study completion, an average of 1 day

Outcome Measure Data

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)
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]
Description	Heart rate in bpm
Time Frame	Through study completion, an average of 1 day

Outcome Measure Data

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)
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]
Description	Respiratory rate in breaths per minute
Time Frame	Through study completion, an average of 1 day

Outcome Measure Data

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)
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
Description	SpO2 measured as percentage of oxygen saturation (%).
Time Frame	Through study completion, an average of 1 day

Outcome Measure Data

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)
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)
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

Outcome Measure Data

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)
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)
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
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

Outcome Measure Data

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)
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
Description	Patient blood pressure (diastolic) measured in mmHg
Time Frame	Through study completion, an average of 1 day

Outcome Measure Data

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)
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)

Adverse Events

Time Frame	8 hours
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Treatment as Usual	High Velocity Nasal Insufflation
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%)
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: George C. Dungan, II
• Organization: Vapotherm, Inc.
• Phone: (267)347-3305
• EMail: gdungan@vtherm.com

• 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