HVNI Ambulation Feasibility Study

Not Applicable

Completed

Conditions: Respiratory Insufficiency
Dyspnea

Interventions: Device: Precision Flow Plus
Device: Treatment as Usual

Registration Number: NCT03885726

Lead Sponsor: Vapotherm, Inc.

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Velocity Nasal Insufflation	Precision Flow Plus	-
Treatment as Usual	Treatment as Usual	-

Primary Outcome Measures

Name	Time	Method
Exercise Performance- Duration	Through study completion, an average of 1 day	Defined as the duration of patient ambulation
Exercise Performance- Distance	Through study completion, an average of 1 day	Defined as the distance of patient ambulation

Secondary Outcome Measures

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

Trial Locations

Locations (3): Midwest Chest Consultants
🇺🇸
Saint Charles, Missouri, United States
Knox Community Hospital
🇺🇸
Mount Vernon, Ohio, United States
Riverside Regional Medical Center
🇺🇸
Newport News, Virginia, United States