N/A
N=26
Does Endurance Improve With the Use of Passy-Muir Valve for Patients With Tracheostomy?
PMV · Exercise Endurance · Tracheostomy
Bottom Line
View on ClinicalTrials.gov: NCT04941456 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Six Minute Walk Test - First Paired Sessions — 413; 387 Feet — p=0.2795
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Open Tracheostomy (Other); PMV in place (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gaylord Hospital, Inc
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Six Minute Walk Test - First Paired Sessions |
413; 387 | 0.2795 |
| PRIMARY Six Minute Walk Test - Second Paired Sessions |
350; 384.6 | — |
| PRIMARY Six Minute Walk Test - Third Paired Sessions |
380; 357.5 | — |
| PRIMARY Average Change of Borg Rating of Perceived Exertion - First Paired Sessions |
4.35; 3.65 | 0.3416 |
| PRIMARY Average Change of Borg Rating of Perceived Exertion - Second Paired Sessions |
6; 5.8 | — |
| PRIMARY Average Change of Borg Rating of Perceived Exertion - Third Paired Sessions |
4.5; 8 | — |
| SECONDARY Change in Heart Rate - First Paired Sessions |
18; 15.4 | — |
| SECONDARY Change in Oxygen Saturation - First Paired Sessions |
-3.6; -2.3 | — |
| SECONDARY Active Standing Time - First Paired Sessions |
259; 257 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Ability to understand and respond to simple verbal instructions and one step commands in English well enough to consent without any interpretation.
- Ability to ambulate a minimum of 10 feet with/without assistive device and with/without physical assistance.
Exclusion Criteria
- Active seizures
- Active Pregnancy
- Uncontrolled hypertension
- Cognitive deficits that would disrupt ability to provide informed consent
- Enteric infection control precautions
- Ongoing orthostasis
- Actively on decannulation protocol
- Medical instability that would cause a doctor to put therapy program on hold
Data sourced from ClinicalTrials.gov (NCT04941456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.