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

NCT04941456 | Completed Results FDA Device

• 1 other identifier: 202104CUT
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Tracheostomy; PMV; Exercise Endurance

Keywords

Tracheostomy; PMV; Passy Muir Valve; Activity Tolerance; Intra-Thoracic Pressure; Six minute walk test; Borg Rating of Perceived Exertion; Oxygen Saturation

Outcome Measures

Primary Outcomes (6)

• Six Minute Walk Test - First Paired Sessions

  During each session, Participants will be asked to walk as far as possible along a corridor for a period of six minutes. The distance the Participant walks will be recorded to compare if the Participant can walk further with or without the PMV in place. Participant can use a device to assist with balance and the Participant can be assisted by an investigator, if needed. Each session is scheduled in an alternating fashion for whether or not Participant will use the PMV (i.e. day one no PMV, day two with PMV, day three no PMV, day four with PMV). Participants will complete 3 sessions with the PMV in place and 3 sessions with an open tracheostomy. Study sessions will occur on consecutive days, five days a week, Monday through Friday, until a minimum of 2 to maximum of 6 sessions are completed. This will equate to 1 to 3 completed paired sessions.

  The first paired study session (Day 1) will occur within 72 hours of the participant being cleared by Medical Staff for PMV use. The second paired session will occur the day after session 1 (Day 2).

• Six Minute Walk Test - Second Paired Sessions

  During each session, Participants will be asked to walk as far as possible along a corridor for a period of six minutes. The distance the Participant walks will be recorded to compare if the Participant can walk further with or without the PMV in place. Participant can use a device to assist with balance and the Participant can be assisted by an investigator, if needed. Each session is scheduled in an alternating fashion for whether or not Participant will use the PMV (i.e. day one no PMV, day two with PMV, day three no PMV, day four with PMV). Participants will complete 3 sessions with the PMV in place and 3 sessions with an open tracheostomy. Study sessions will occur on consecutive days, five days a week, Monday through Friday, until a minimum of 2 to maximum of 6 sessions are completed. This will equate to 1 to 3 completed paired sessions.

  The third study session (Day 3) will occur the day following the second study session (Day 2). The fourth study session (Day 4) will occur the day following the third study session (Day 3).

• Six Minute Walk Test - Third Paired Sessions

  During each session, Participants will be asked to walk as far as possible along a corridor for a period of six minutes. The distance the Participant walks will be recorded to compare if the Participant can walk further with or without the PMV in place. Participant can use a device to assist with balance and the Participant can be assisted by an investigator, if needed. Each session is scheduled in an alternating fashion for whether or not Participant will use the PMV (i.e. day one no PMV, day two with PMV, day three no PMV, day four with PMV). Participants will complete 3 sessions with the PMV in place and 3 sessions with an open tracheostomy. Study sessions will occur on consecutive days, five days a week, Monday through Friday, until a minimum of 2 to maximum of 6 sessions are completed. This will equate to 1 to 3 completed paired sessions.

  The fifth study session (Day 5) will occur the day following the fourth study session (Day 4). The sixth study session (Day 6) will occur the day following the fifth study session (Day 5).

• Average Change of Borg Rating of Perceived Exertion - First Paired Sessions

  Borg Rating of Perceived Exertion is a self reported outcome score, based on a scale of 6 through 20 (20 being the hardest or most exertion, 6 being the least exertion). The first session will occur within 72 hours of the participant being cleared by Medical Staff for PMV use. Subsequent sessions will occur on every consecutive day following for 6 days total, Monday through Friday, until a minimum of 2 to maximum of 6 sessions are completed. This will equal 1 to 3 paired sessions. Average change will be calculated by using Post intervention scores subtracted by Pre intervention scores.

  The first paired study session (Day 1) will occur within 72 hours of the participant being cleared by Medical Staff for PMV use. The second paired session will occur the day after session 1 (Day 2).

• Average Change of Borg Rating of Perceived Exertion - Second Paired Sessions

  Borg Rating of Perceived Exertion is a self reported outcome score, based on a scale of 6 through 20 (20 being the hardest or most exertion, 6 being the least exertion). The first session will occur within 72 hours of the participant being cleared by Medical Staff for PMV use. Subsequent sessions will occur on every consecutive day following for 6 days total, Monday through Friday, until a minimum of 2 to maximum of 6 sessions are completed. This will equal 1 to 3 paired sessions. Average change will be calculated by using Post intervention scores subtracted by Pre intervention scores.

  The third study session (Day 3) will occur the day following the second study session (Day 2). The fourth study session (Day 4) will occur the day following the third study session (Day 3).

• Average Change of Borg Rating of Perceived Exertion - Third Paired Sessions

  Borg Rating of Perceived Exertion is a self reported outcome score, based on a scale of 6 through 20 (20 being the hardest or most exertion, 6 being the least exertion). The first session will occur within 72 hours of the participant being cleared by Medical Staff for PMV use. Subsequent sessions will occur on every consecutive day following for 6 days total, Monday through Friday, until a minimum of 2 to maximum of 6 sessions are completed. This will equal 1 to 3 paired sessions. Average change will be calculated by using Post intervention scores subtracted by Pre intervention scores.

  The fifth study session (Day 5) will occur the day following the fourth study session (Day 4). The sixth study session (Day 6) will occur the day following the fifth study session (Day 5).

Secondary Outcomes (3)

• Change in Heart Rate - First Paired Sessions

  Participant heart rate will be measured just prior and immediately after each intervention.

• Change in Oxygen Saturation - First Paired Sessions

  Participant oxygen saturation will be measured just prior and immediately after each intervention.

• Active Standing Time - First Paired Sessions

  Participant active standing time will be recorded immediately after each intervention.

Study Arms (2)

Open Tracheostomy, Then Speaking Valve

EXPERIMENTAL

Participants perform the six-minute walk test each study session to assess ambulation distance, first using with an open tracheostomy on day 1 and then switching to a Passy-Muir Valve on day 2. Participants will alternate back and forth between open tracheostomy and Passy-Muir Valve until 3 sessions are completed with each condition.

Other: Open Tracheostomy; Device: PMV in place

Speaking Valve, Then Open Tracheostomy

EXPERIMENTAL

Participants perform the six-minute walk test each study session to assess ambulation distance, first using the Passy-Muir Valve on day 1 and then switching to an open tracheostomy on day 2. Participants will alternate back and forth between the Passy-Muir Valve and open tracheostomy until 3 sessions are completed with each condition.

Other: Open Tracheostomy; Device: PMV in place

Interventions

Open Tracheostomy OTHER

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

Also known as: Standard

Open Tracheostomy, Then Speaking Valve; Speaking Valve, Then Open Tracheostomy

PMV in place DEVICE

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

Also known as: PMV, Passy-Muir Valve

Open Tracheostomy, Then Speaking Valve; Speaking Valve, Then Open Tracheostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaylord Hospital, Inc: lead

Study Sites (1)

Gaylord Hospital

Wallingford, Connecticut, 06492, United States

Location

Related Publications (4)

• Massery M, Hagins M, Stafford R, Moerchen V, Hodges PW. Effect of airway control by glottal structures on postural stability. J Appl Physiol (1985). 2013 Aug 15;115(4):483-90. doi: 10.1152/japplphysiol.01226.2012. Epub 2013 Jun 13.

  PMID: 23766504 BACKGROUND

• Roberts KJ. Enhancing Early Mobility With a Speaking Valve. Respir Care. 2020 Feb;65(2):269-270. doi: 10.4187/respcare.07671. No abstract available.

  PMID: 31988255 BACKGROUND

• Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.

  PMID: 31689414 BACKGROUND

• Ceron C, Otto D, Signorini AV, Beck MC, Camilis M, Sganzerla D, Rosa RG, Teixeira C. The Effect of Speaking Valves on ICU Mobility of Individuals With Tracheostomy. Respir Care. 2020 Feb;65(2):144-149. doi: 10.4187/respcare.06768. Epub 2019 Oct 15.

  PMID: 31615923 BACKGROUND

Related Links

• Borg Rating of Perceived Exertion; Physio-Pedia

Results Point of Contact

• Title: Dr. Henry Hrdlicka
• Organization: Gaylord Hospital, Inc.

hhrdlicka@gaylord.org

203-284-2864

Study Officials

• Erica Cutler, DPT

  Gaylord Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants and care providers are unable to be masked to the intervention arm due to the nature of the study. As data was collected, investigators were unable to blind the data prior to exporting.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 6 period Quasi-Randomized Crossover Controlled Study. Enrollment will occur based off tracheostomy census report, site investigators will perform weekly pull of tracheostomy report to recruit appropriate patients.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 28, 2021
• Study Start: July 29, 2021
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: December 11, 2025
• Results First Posted: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)