CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Open Tracheostomy +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04941456
NCT04941456N/ACompleted

Is Ambulation Distance on the Six-minute Walk Test Improved With the Use of Passy-Muir Valve for Patients With Tracheostomy Compared to Patients With an Open Tracheostomy?

Gaylord Hospital, Inc·interventional·Posted Jun 28, 2021·Updated Dec 11, 2025

In Brief

A clinical study evaluating Open Tracheostomy and PMV in place for PMV and 2 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 28, 2021
Enrollment StartJul 29, 2021
Primary CompletionJun 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 5.0 years ago

Interventions

Open Tracheostomyother

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

PMV in placedevice

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