Passy-Muir Valve for Exercise Endurance in Tracheostomy Patients

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gaylord Hospital, Inc

Disqualifiers: Seizures, Pregnancy, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1-2 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if the use of the Passy-Muir Valve improves endurance for patients in the Long Term Acute Care setting as measured with the Six- Minute Walk Test.

Research Team

Erica Cutler, DPT

Principal Investigator

Gaylord Hospital

Eligibility Criteria

This trial is for individuals with a tracheostomy who can handle daily 30-minute physical therapy sessions using the Passy-Muir Valve (PMV) and walk at least 10 feet. They must keep oxygen levels above 88% when active, understand English commands to consent, and not be on a decannulation protocol or have conditions like uncontrolled high blood pressure.

Inclusion Criteria

I have a tracheostomy, can do 30 min of physical therapy daily, and keep my oxygen levels above 88% when active.

Ability to understand and respond to simple verbal instructions and one step commands in English well enough to consent without any interpretation

I can walk at least 10 feet on my own or with help or a device.

Exclusion Criteria

My high blood pressure is not under control.

I currently experience seizures.

I am able to understand and make decisions about my health care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants perform the Six-Minute Walk Test with alternating use of Passy-Muir Valve and open tracheostomy over 6 sessions

1-2 weeks

6 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Open Tracheostomy
• PMV in place

Trial Overview The study tests if endurance improves in long-term acute care patients with tracheostomies using the PMV. Endurance is measured by how far participants can walk in six minutes while wearing the valve during their physical therapy sessions.

Participant Groups

Group I: PMV in place Experimental Treatment 1 Intervention

Participants will perform the six-minute walk test each session to assess ambulation distance, alternating between the open tracheostomy (standard) versus the Passy-Muir Valve in place intervention on sequential days to compare results.

Group II: Open Tracheostomy Active Control 1 Intervention

Participants will perform the six-minute walk test each session to assess ambulation distance, alternating between the open tracheostomy (standard) versus the Passy-Muir Valve in place intervention on sequential days to compare results.

Who Is Running the Clinical Trial?

Gaylord Hospital, Inc

Lead Sponsor

Trials

7

Recruited

330+