Your session is about to expire
← Back to Search
Behavioural Intervention
Passy-Muir Valve for Exercise Endurance in Tracheostomy Patients
N/A
Waitlist Available
Led By Erica Cutler, DPT
Research Sponsored by Gaylord Hospital, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participant oxygen saturation will be measured just prior and immediately after each intervention.
Awards & highlights
Study Summary
This trial will test if using the Passy-Muir Valve can help people in long-term care stay active longer, as measured by the Six-Minute Walk Test.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed for this intervention, general risks may include discomfort from wearing the PMV, potential breathing difficulties during exertion, or skin irritation around the tracheostomy site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the first study session (day 1 ) will occur within 72 hours of the participant being cleared by medical staff for pmv use.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the first study session (day 1 ) will occur within 72 hours of the participant being cleared by medical staff for pmv use.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Change of Borg Rating of Perceived Exertion - Session 1 (Day 1)
Average Change of Borg Rating of Perceived Exertion - Session 2 (Day 2)
Average Change of Borg Rating of Perceived Exertion - Session 3 (Day 3)
+9 moreSecondary outcome measures
Active standing time
Heart Rate
Oxygen Saturation
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PMV in placeExperimental Treatment1 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 TracheostomyActive Control1 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.
Find a Location
Who is running the clinical trial?
Gaylord Hospital, IncLead Sponsor
6 Previous Clinical Trials
288 Total Patients Enrolled
Erica Cutler, DPTPrincipal InvestigatorGaylord Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My high blood pressure is not under control.I currently experience seizures.I am able to understand and make decisions about my health care.I often feel dizzy when standing up.I have a tracheostomy, can do 30 min of physical therapy daily, and keep my oxygen levels above 88% when active.I am currently following a plan to remove my breathing tube.I can walk at least 10 feet on my own or with help or a device.My doctor considers my health too unstable for therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Open Tracheostomy
- Group 2: PMV in place
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study currently open to enrolment?
"According to clinicaltrials.gov, this trial has finished recruiting and is no longer actively seeking new enrollees. It was first posted on July 29th 2021 with the last update occuring on July 20th 2022. However, there are 6 other studies that are presently enrolling patients at this time."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger