HVNI Ambulation Feasibility Study

Dyspnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885726
• Other study ID #: RP-VTPF2018001Sci
• Status: Completed
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: March 11, 2019

Study information

• Verified date: September 2020
• Source: Vapotherm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 11, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

Device:
• Precision Flow Plus
High velocity nasal insufflation
• Treatment as Usual
Conventional therapy per institution

Locations

Country	Name	City	State
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Riverside Regional Medical Center	Newport News	Virginia
United States	Midwest Chest Consultants	Saint Charles	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Vapotherm, Inc.	Knox Community Hospital, Midwest Chest Consultants, Riverside Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Performance- Distance	Defined as the distance of patient ambulation	Through study completion, an average of 1 day
Primary	Exercise Performance- Duration	Defined as the duration of patient ambulation	Through study completion, an average of 1 day
Secondary	Patient Recovery Interval	Defined as recovery time (return time to baseline rated perceived dyspnea).	Through study completion, an average of 1 day
Secondary	Patient Vital Signs - Blood Pressure	Patient blood pressure (systolic) measured in mmHg	Through study completion, an average of 1 day
Secondary	Patient Vital Signs-- Heart Rate [HR]	Heart rate in bpm	Through study completion, an average of 1 day
Secondary	Patient Vital Signs-- Respiratory Rate [RR]	Respiratory rate in breaths per minute	Through study completion, an average of 1 day
Secondary	Patient Vital Signs-- Arterial Oxygen Saturation	SpO2 measured as percentage of oxygen saturation (%).	Through study completion, an average of 1 day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient Vital Signs - Blood Pressure	Patient blood pressure (diastolic) measured in mmHg	Through study completion, an average of 1 day