HVNI Ambulation Feasibility Study

Assessing Clinical Effect of HVNI on Patient Ambulation in Acute Care Scenarios: a Feasibility Study

The pilot/feasibility study evaluates the ability of High Velocity Nasal Insufflation (HVNI) therapy to facilitate ambulation and mobilization in patients experiencing shortness of breath, as compared to simple oxygen therapy.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Dyspnea
• Intervention / Treatment: Device: Treatment as Usual; Device: Precision Flow Plus

Detailed Description

The hypothesis is that HVNI therapy, when implemented in conjunction to ambulatory practices, will be more effective than TAU to improve patient mobility by reducing the patient's perceived dyspnea and exertion via maintaining oxygenation (reduced desaturation) and supporting ventilation (reduced work of breathing [WOB]). The primary endpoint is exercise performance, defined as the distance and duration of patient ambulation.

To provide a sample data set, The investigators will enroll up to 32 subjects to complete this feasibility assessment, with a calculated sample size of N=26 plus a 20% failure rate. This will provide sufficient initial data to inform the appropriate sample size of a follow-on randomized study.

This will be a feasibility study, performed as a prospective, crossover controlled trial to evaluate the potential patient improvement during ambulation while on HVNI relative to TAU. Patients who fit the criteria for inclusion will perform ambulation for each study arm: the control arm (TAU) followed by the test arm (HVNI). Control group will receive the site TAU (not HVNI), and the test group will receive HVNI therapy. In both cases the clinical management will otherwise remain unchanged based on the site SOC practices. The patient FiO2 and flow values will be recorded while on any supplemental oxygen. Subjects will wear appropriate gear and, when applicable, have mobile carts to provide supplemental oxygen therapy (e.g. HVNI VTU) during ambulation. If they meet criteria for intubation or are deemed to need intubation by the critical care team, they will undergo prompt intubation and be managed according to standard practice. After each of the study arms, the clinicians will complete perception score assessments.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Charles, Missouri, United States, 63301
      • Midwest Chest Consultants
  • Ohio
    • Mount Vernon, Ohio, United States, 43050
      • Knox Community Hospital
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Riverside Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults over the age of 18 years
• Demonstrated respiratory distress upon mild to moderate exertion (e.g. dyspnea upon standing, walking, etc.)
• Candidate for clinical ambulation/mobilization

Exclusion Criteria:

• Hypoxemia at resting baseline: unable to maintain SpO2≥88% with supplemental oxygen
• Inability to provide informed consent
• Pregnancy
• Known contraindication to perform ambulation, per site SOC practices
• Inadequate respiratory drive or any known contraindications to HVNI
• Inability to use nasal cannula and HVNI therapy
• Agitation or uncooperativeness
• Determined by the attending clinician to be sufficiently unstable or unsuitable for this feasibility study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as Usual	Device: Treatment as Usual; Conventional therapy per institution
Experimental: High Velocity Nasal Insufflation	Device: Precision Flow Plus; High velocity nasal insufflation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Recovery Interval	Defined as recovery time (return time to baseline rated perceived dyspnea).	Through study completion, an average of 1 day
Patient Vital Signs - Blood Pressure	Patient blood pressure (systolic) measured in mmHg	Through study completion, an average of 1 day
Patient Vital Signs-- Heart Rate [HR]	Heart rate in bpm	Through study completion, an average of 1 day
Patient Vital Signs-- Respiratory Rate [RR]	Respiratory rate in breaths per minute	Through study completion, an average of 1 day
Patient Vital Signs-- Arterial Oxygen Saturation	SpO2 measured as percentage of oxygen saturation (%).	Through study completion, an average of 1 day
Patient Vital Signs-- Rated Perceived Exertion (RPE)	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.	Through study completion, an average of 1 day
Patient Vital Signs-- Rated Perceived Dyspnea (RPD)	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.	Through study completion, an average of 1 day
Clinician Perception Score- Patient Response to Therapy	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.	Through study completion, an average of 1 day
Clinician Perception Score- Patient Tolerance and Comfort	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.	Through study completion, an average of 1 day
Clinician Perception Score- Frequency of Technical/Clinical Difficulties	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.	Through study completion, an average of 1 day
Clinician Perception Score- Simplicity of Set-up and Use	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.	Through study completion, an average of 1 day
Clinician Perception Score- Support/Adjustment Required	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.	Through study completion, an average of 1 day
Patient Vital Signs - Blood Pressure	Patient blood pressure (diastolic) measured in mmHg	Through study completion, an average of 1 day

Collaborators and Investigators

• Sponsor: Vapotherm, Inc.
• Collaborators: Knox Community Hospital; Riverside Regional Medical Center; Midwest Chest Consultants
• Investigators: Principal Investigator: Shailesh Patel, MD, Knox Community Hospital; Principal Investigator: Thomas M Siler, MD, Midwest Chest Consultants; Principal Investigator: Paragkumar Amin, MD, Riverside Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): March 11, 2019

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 23, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Dyspnea
• Other Study ID Numbers: RP-VTPF2018001Sci

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No