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

NCT04941456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-12-11

Study results available
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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.

Conditions

  • PMV
  • Exercise Endurance
  • Tracheostomy

Interventions

OTHER

Open Tracheostomy

Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks.

DEVICE

PMV in place

Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.

Sponsors & Collaborators

  • Gaylord Hospital, Inc

    lead OTHER

Principal Investigators

  • Erica Cutler, DPT · Gaylord Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-29
Primary Completion
2024-06-24
Completion
2024-06-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941456 on ClinicalTrials.gov