HVNI Ambulation Feasibility Study

NCT ID: NCT03885726

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-21
• Study Completion Date: 2019-03-11

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.

Conditions

Respiratory Insufficiency; Dyspnea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment as Usual

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: DEVICE

Conventional therapy per institution

High Velocity Nasal Insufflation

Group Type: EXPERIMENTAL

Precision Flow Plus

Intervention Type: DEVICE

High velocity nasal insufflation

Interventions

Precision Flow Plus

High velocity nasal insufflation

Intervention Type: DEVICE

Treatment as Usual

Conventional therapy per institution

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Knox Community Hospital

OTHER

Sponsor Role: collaborator

Riverside Medical Center

OTHER

Sponsor Role: collaborator

Midwest Chest Consultants

OTHER

Sponsor Role: collaborator

Vapotherm, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shailesh Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Knox Community Hospital

Thomas M Siler, MD

Role: PRINCIPAL_INVESTIGATOR

Midwest Chest Consultants

Paragkumar Amin, MD

Role: PRINCIPAL_INVESTIGATOR

Riverside Medical Center

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RP-VTPF2018001Sci

Identifier Type: -

Identifier Source: org_study_id