HVNI Ambulation Feasibility Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Insufficiency, Dyspnea

Intervention / Treatment
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* Device: Precision Flow Plus
* Device: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as Usual<br> | Device: Treatment as Usual<br>* Conventional therapy per institution<br>|
| Experimental: High Velocity Nasal Insufflation<br> | Device: Precision Flow Plus<br>* High velocity nasal insufflation<br>|

What is the study measuring?
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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 |