Clinical trial NCT03885726: HVNI Ambulation Feasibility Study
Official title: Assessing Clinical Effect of HVNI on Patient Ambulation in Acute Care Scenarios: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Dyspnea
Lead sponsor: Vapotherm, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Knox Community Hospital
name: Riverside Medical Center
name: Midwest Chest Consultants
First posted: 2019-03-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exercise Performance- Distance
timeFrame: Through study completion, an average of 1 day
measure: Exercise Performance- Duration
timeFrame: Through study completion, an average of 1 day
Secondary outcomes:
measure: Patient Recovery Interval
timeFrame: Through study completion, an average of 1 day
measure: Patient Vital Signs - Blood Pressure
timeFrame: Through study completion, an average of 1 day
measure: Patient Vital Signs-- Heart Rate [HR]
timeFrame: Through study completion, an average of 1 day
measure: Patient Vital Signs-- Respiratory Rate [RR]
timeFrame: Through study completion, an average of 1 day
measure: Patient Vital Signs-- Arterial Oxygen Saturation
timeFrame: Through study completion, an average of 1 day
measure: Patient Vital Signs-- Rated Perceived Exertion (RPE)
timeFrame: Through study completion, an average of 1 day
measure: Patient Vital Signs-- Rated Perceived Dyspnea (RPD)
timeFrame: Through study completion, an average of 1 day
measure: Clinician Perception Score- Patient Response to Therapy
timeFrame: Through study completion, an average of 1 day
measure: Clinician Perception Score- Patient Tolerance and Comfort
timeFrame: Through study completion, an average of 1 day
measure: Clinician Perception Score- Frequency of Technical/Clinical Difficulties
timeFrame: Through study completion, an average of 1 day
measure: Clinician Perception Score- Simplicity of Set-up and Use
timeFrame: Through study completion, an average of 1 day
measure: Clinician Perception Score- Support/Adjustment Required
timeFrame: Through study completion, an average of 1 day
measure: Patient Vital Signs - Blood Pressure
timeFrame: Through study completion, an average of 1 day
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Midwest Chest Consultants
state: Missouri
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newport News
country: United States
facility: Riverside Regional Medical Center
state: Virginia
Study officials:
affiliation: Knox Community Hospital
name: Shailesh Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Midwest Chest Consultants
name: Thomas M Siler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Riverside Medical Center
name: Paragkumar Amin, MD
role: PRINCIPAL_INVESTIGATOR
References: