Does Endurance Improve With the Use of Passy-Muir Valve for Patients With Tracheostomy?

Launched by GAYLORD HOSPITAL, INC · Jun 24, 2021

Keywords

ClinConnect Summary

This study is testing whether using a Passy-Muir Valve (PMV) on a tracheostomy helps people with long-term tracheostomies walk farther and feel less effort during movement. Researchers will measure endurance with a 6-minute walk test and compare performance on days with the PMV in place versus days with an open tracheostomy (no PMV). Each participant Clinic will experience both conditions in a series of sessions, so they act as their own comparison. About 30 adults are planned to enroll, and results will come from comparing distance walked and how hard the effort feels.

Who can join? Adults 18 years or older with a tracheostomy who can do daily 30 minutes of physical therapy and keep oxygen levels above about 88% during activity, can follow simple instructions, and can walk at least 10 feet with or without help. People with active seizures, pregnancy, very high blood pressure that isn’t controlled, significant cognitive problems, certain infection precautions, or medical instability are not eligible. If eligible, you’ll have several walking sessions over a few weeks (roughly 2–6 sessions, Monday–Friday). During sessions, heart rate and oxygen saturation will be checked before and after, and you’ll rate how hard the exercise feels using a standard scale. The study is taking place at Gaylord Hospital in Wallingford, Connecticut, and results are not yet available; the study is expected to finish around January 2025.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Individual with tracheostomy who can tolerate daily 30 minute Physical Therapy sessions with use of PMV and be able to maintain oxygen saturations above 88% with exertion.
• • 2. Ability to understand and respond to simple verbal instructions and one step commands in English well enough to consent without any interpretation.
• • 3. Ability to ambulate a minimum of 10 feet with/without assistive device and with/without physical assistance.
• Exclusion Criteria:
• • 1. Active seizures
• • 2. Active Pregnancy
• • 3. Uncontrolled hypertension
• • 4. Cognitive deficits that would disrupt ability to provide informed consent
• • 5. Enteric infection control precautions
• • 6. Ongoing orthostasis
• • 7. Actively on decannulation protocol
• • 8. Medical instability that would cause a doctor to put therapy program on hold