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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Passy-Muir Valve, a device used with tracheostomies, can improve exercise endurance in patients requiring long-term acute care. Participants will alternate between the standard open tracheostomy and the Passy-Muir Valve during a six-minute walk test to determine which setup allows them to walk farther. It suits individuals with a tracheostomy who can undergo daily physical therapy and walk at least 10 feet, with or without assistance. As an unphased trial, this study provides patients the chance to contribute to valuable research that could enhance the quality of life for those with tracheostomies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Passy-Muir Valve is safe for tracheostomy patients?

Previous studies have shown that the Passy-Muir Valve is safe for patients with tracheostomy tubes. Research indicates that this valve can help patients talk, improve swallowing, and reduce the risk of aspiration. It also aids in breathing. Patients who used the valve for two hours or more did not experience any major safety issues. Overall, the Passy-Muir Valve is well-tolerated for those who need this kind of support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing the Passy-Muir Valve (PMV) with the standard open tracheostomy method because it could enhance exercise endurance in tracheostomy patients. The PMV is a unique device that allows patients to speak and breathe more naturally by redirecting airflow through the vocal cords. This could potentially improve lung function and overall mobility during physical activities, which isn't typically achieved with standard open tracheostomy methods. By alternating the use of the PMV with the open tracheostomy during exercise tests, researchers hope to uncover the PMV's benefits on endurance and quality of life for these patients.

What evidence suggests that the Passy-Muir Valve is effective for improving exercise endurance in tracheostomy patients?

This trial will compare the effects of using the Passy-Muir Valve (PMV) with an open tracheostomy on exercise endurance in tracheostomy patients. Research has shown that the Passy-Muir Valve can help these patients exercise longer. Studies have found that using the valve increases chest pressure, aiding breathing and endurance. Additionally, the valve improves communication, swallowing, and strengthens the diaphragm, which can help patients walk further. These findings suggest that the valve might help tracheostomy patients feel stronger and less tired during activities like walking. Overall, evidence supports the idea that the Passy-Muir Valve could effectively improve endurance for these patients. ^{5 6 7 8 9}

Who Is on the Research Team?

Erica Cutler, DPT

Principal Investigator

Gaylord Hospital

Are You a Good Fit for This Trial?

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.

Enteric infection control precautions

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04941456

Does Endurance Improve With the Use of Passy-Muir ... Use of the PMV during physical therapy helps restore the pressure support in the trunk, allowing for natural increases in intra-thoracic pressure (ITP) and ...

2. passy-muir.com passy-muir.com/sites/default/files/pdf/pm-newsletter-fall-2011.pdf

Rehabilitation Issue The Passy-Muir® Valve plays a vital role in the rehabilitation of adult and pediatric tracheostomy and ventilator patients throughout the continuum of care.

3. clinicaltrial.be clinicaltrial.be/en/details/176371?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Does Endurance Improve With the Use of Passy-Muir ... PMVs provide patients with the ability to communicate, swallow, and improve diaphragmatic strength, which lengthens the periods of time that ...

4. gaylord.org gaylord.org/research-listing/does-endurance-improve-with-the-use-of-passy-muir-valve

Does Endurance Improve with the use of Passy-Muir Valve ... The purpose of this study is to determine if the use of the Passy-Muir Valve improves endurance for patients in long term acute care setting ...

5. passy-muir.com passy-muir.com/talkmuir-6-1-mechanical-vent/

Speaking Valve Use During Mechanical Ventilation Inspiratory Muscle Training (IMT) has been reported to increase exercise endurance, muscle strength, and perceived dyspnea in patients with COPD (Geddes, O ...

6. passy-muir.com passy-muir.com/talkmuir-6-1-current-research/

Current Research Related to Mechanical Ventilation and ... Research has demonstrated that patients with prolonged use of tracheostomized mechanical ventilation have a high prevalence of dysphagia and respiratory ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11657657/

Application and safety of speaking valves in tracheostomy ... A speaking valve, attached to the tracheostomy tube, allows speech and improves swallowing, reduces aspiration risk, and enhances lung mechanics.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1036731420303039

The safety and efficacy of prolonged use of one-way ... The prolonged use of a one-way speaking valve was safe in patients who reached a threshold of 2 h (and predominantly spontaneously ventilating patients).

9. passy-muir.com passy-muir.com/journal-3-1-patient-outcomes/

Having Protocols for Clinical Use to Improve Patient ... The Passy Muir® Valve (PMV®) is a speaking Valve that is placed on the end of a tracheostomy tube or in-line with ventilator circuitry. It allows air intake to ...