PMVNCT04941456
Does Endurance Improve With the Use of Passy-Muir Valve for Patients With Tracheostomy?
A study testing Open Tracheostomy and PMV in place in people with PMV and Exercise Endurance, run by Gaylord Hospital, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PMV, Exercise Endurance, Tracheostomy
- What is being tested?
- Open Tracheostomy and PMV in place
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2021to 24 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
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.
Read the detailed description
A Passy-Muir Valve (PMV) is a one-way valve that blocks air flow from exhalation in patients with a tracheostomy, and redirects it through to the upper airway to enable functional use of the glottis.
Typically, PMVs are used to assist patients being weaned from mechanical ventilation to communicate more effectively after tracheostomy. Devices are available that can be used in-line with the ventilator, as well as after ventilator liberation with a tracheostomy collar. PMVs provide patients with the ability to communicate, swallow, and improve diaphragmatic strength, which lengthens the periods of time that patients remain free from ventilator assistance, which ultimately leads to decannulation.
Use of the PMV during physical therapy helps restore the pressure support in the trunk, allowing for natural increases in intra-thoracic pressure (ITP) and intra-abdominal pressures (IAP) in response to increased postural demands. With an open tracheostomy tube and therefore, an open system, thoracic pressures cannot be increased or sustained as airflow passes through the tracheostomy tube and bypasses the upper airway. This difficulty would be observed when a patient needs to crawl, sit, push, or stand up. The typical means of gross motor movement for mobility is to engage the glottis (vocal cords) to restrict the expiratory lung volume in order to stabilize the chest and upper body. Placing a PMV on the tracheostomy tube closes the system and restores a patient's ability to use the upper airway to control expiratory flow and improve ITP and IAP.
The Six-Minute Walk Test (6MWT) is a commonly used test for the objective assessment of functional exercise capacity for management of patients with moderate to severe pulmonary disease. The patient is asked to walk as far as possible along a 30 meter minimally trafficked corridor for a period of six minutes. The 6MWT is a safe test with rare complications, the most common adverse event is oxygen desaturation below 80%.
Participants will consist of inpatients with tracheostomy who can tolerate use of Passy-Muir Valve; participants will be approached and consented into the study within 72 hours of being deemed medically appropriate for PMV use by medical staff. The 6MWT will be administered each session to assess ambulation distance, alternating open tracheostomy vs Passy-Muir Valve in place on sequential days to compare results. The Borg Rating of Perceived Exertion (RPE) scale will be administered before and after each session to assess patient's subjective rating of physical exertion levels on a scale from 6 through 20; 20 being the most exertion possible. Oxygen saturation and heart rate will be monitored before and after each session via pulse oximeter to assess for physiologic appropriateness of exercise response. For safety of the participant, while performing the six-minute walk test, participants will be allowed to use assistive devices as prescribed by the participant's primary physical therapist.
Sample size: A convenience sample of 30 participants will be collected.
Data: All data will be collected and analyzed in a paired fashion as appropriate; adjustments for abnormal distribution, unequal variance, and repeated measure will be applied as necessary. In the case of missing or inconsistent data due to early withdraw, early participant discharge, or other unforeseen events, the datasets will be evaluated as normal. Paired T-test and Repeated Measures Analysis of Variance (ANOVA) will be conducted to evaluate differences in Borg RPE scores and six-minute walk tests, between treatment arms, as appropriate. Correlation analysis may also be conducted to evaluate if there is any correlation to treatment arm, Borg RPE scores, six-minute walk test, and other variables such as session number.
- Conditions
- PMV, Exercise Endurance, Tracheostomy
- Being tested
- Open Tracheostomy, PMV in place
- Keywords
- Tracheostomy, PMV, Passy Muir Valve, Activity Tolerance, Intra-Thoracic Pressure, Six minute walk test, Borg Rating of Perceived Exertion, Oxygen Saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open TracheostomyOther
Also called Standard
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
Also called PMV, Passy-Muir Valve
Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Open Tracheostomy; Device: PMV in place |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Using a finger pulse-oxygen meter. These are paired data from session 1 and session 2. Change will be calculated using Post intervention scores minus Pre intervention scores.
Measured: Participant heart rate will be measured just prior and immediately after each intervention.
Change in Oxygen Saturation - First Paired Sessions
Using a finger pulse-oxygen meter. These are paired data from session 1 and session 2. Change will be calculated using Post intervention scores minus Pre intervention scores.
Measured: Participant oxygen saturation will be measured just prior and immediately after each intervention.
Active Standing Time - First Paired Sessions
The duration of active standing time, including standing rest breaks and active ambulation, that participants are able to tolerate while completing the six-minute walk test will be recorded. These are paired data from session 1 and session 2.
Measured: Participant active standing time will be recorded immediately after each intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start29 Jul 2021
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PMVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaylord Hospital, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica Cutler, DPT, Principal investigator, Gaylord Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941456
- Sponsor's protocol ID
- 202104CUT
- Status last verified
- Dec 2025
- First submitted
- 11 Jun 2021
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Copies of the study protocol will be provided upon reasonable request. Requests for copies of deidentified study data will considered on a case by case basis.
Publications
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.
PubMed 23766504Roberts KJ. Enhancing Early Mobility With a Speaking Valve. Respir Care. 2020 Feb;65(2):269-270. doi: 10.4187/respcare.07671. No abstract available.
PubMed 31988255Agarwala 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.
PubMed 31689414Ceron 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.
PubMed 31615923
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT04941456
- Acronym / sponsor ID
- 202104CUT
- Conditions
- PMV, Exercise Endurance, Tracheostomy
- Keywords
- Tracheostomy, PMV, Passy Muir Valve, Activity Tolerance, Intra-Thoracic Pressure, Six minute walk test, Borg Rating of Perceived Exertion, Oxygen Saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Gaylord Hospital, IncUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Posted 11 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A Passy-Muir Valve (PMV) is a one-way valve that blocks air flow from exhalation in patients with a tracheostomy, and redirects it through to the upper airway to enable functional use of the glottis.
Typically, PMVs are used to assist patients being weaned from mechanical ventilation to communicate more effectively after tracheostomy. Devices are available that can be used in-line with the ventilator, as well as after ventilator liberation with a tracheostomy collar. PMVs provide patients with the ability to communicate, swallow, and improve diaphragmatic strength, which lengthens the periods of time that patients remain free from ventilator assistance, which ultimately leads to decannulation.
Use of the PMV during physical therapy helps restore the pressure support in the trunk, allowing for natural increases in intra-thoracic pressure (ITP) and intra-abdominal pressures (IAP) in response to increased postural demands. With an open tracheostomy tube and therefore, an open system, thoracic pressures cannot be increased or sustained as airflow passes through the tracheostomy tube and bypasses the upper airway. This difficulty would be observed when a patient needs to crawl, sit, push, or stand up. The typical means of gross motor movement for mobility is to engage the glottis (vocal cords) to restrict the expiratory lung volume in order to stabilize the chest and upper body. Placing a PMV on the tracheostomy tube closes the system and restores a patient's ability to use the upper airway to control expiratory flow and improve ITP and IAP.
The Six-Minute Walk Test (6MWT) is a commonly used test for the objective assessment of functional exercise capacity for management of patients with moderate to severe pulmonary disease. The patient is asked to walk as far as possible along a 30 meter minimally trafficked corridor for a period of six minutes. The 6MWT is a safe test with rare complications, the most common adverse event is oxygen desaturation below 80%.
Participants will consist of inpatients with tracheostomy who can tolerate use of Passy-Muir Valve; participants will be approached and consented into the study within 72 hours of being deemed medically appropriate for PMV use by medical staff. The 6MWT will be administered each session to assess ambulation distance, alternating open tracheostomy vs Passy-Muir Valve in place on sequential days to compare results. The Borg Rating of Perceived Exertion (RPE) scale will be administered before and after each session to assess patient's subjective rating of physical exertion levels on a scale from 6 through 20; 20 being the most exertion possible. Oxygen saturation and heart rate will be monitored before and after each session via pulse oximeter to assess for physiologic appropriateness of exercise response. For safety of the participant, while performing the six-minute walk test, participants will be allowed to use assistive devices as prescribed by the participant's primary physical therapist.
Sample size: A convenience sample of 30 participants will be collected.
Data: All data will be collected and analyzed in a paired fashion as appropriate; adjustments for abnormal distribution, unequal variance, and repeated measure will be applied as necessary. In the case of missing or inconsistent data due to early withdraw, early participant discharge, or other unforeseen events, the datasets will be evaluated as normal. Paired T-test and Repeated Measures Analysis of Variance (ANOVA) will be conducted to evaluate differences in Borg RPE scores and six-minute walk tests, between treatment arms, as appropriate. Correlation analysis may also be conducted to evaluate if there is any correlation to treatment arm, Borg RPE scores, six-minute walk test, and other variables such as session number.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open Tracheostomy, Then Speaking Valve | Experimental | Other: Open Tracheostomy, Device: PMV in placeParticipants 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. |
| Speaking Valve, Then Open Tracheostomy | Experimental | Other: Open Tracheostomy, Device: PMV in placeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Active seizures
- Active Pregnancy
- Uncontrolled hypertension
- Cognitive deficits that would disrupt ability to provide informed consent
- Enteric infection control precautions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open TracheostomyAlso: StandardParticipants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks. | Other | Open Tracheostomy, Then Speaking Valve, Speaking Valve, Then Open Tracheostomy |
| PMV in placeAlso: PMV, Passy-Muir ValveParticipants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks. | Device | Open Tracheostomy, Then Speaking Valve, Speaking Valve, Then Open Tracheostomy |
Primary outcome
Six Minute Walk Test - First Paired Sessions
Time frame: 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).
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.
Six Minute Walk Test - Second Paired Sessions
Time frame: 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).
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.
Six Minute Walk Test - Third Paired Sessions
Time frame: 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).
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.
Average Change of Borg Rating of Perceived Exertion - First Paired Sessions
Time frame: 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).
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.
Average Change of Borg Rating of Perceived Exertion - Second Paired Sessions
Time frame: 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).
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.
Average Change of Borg Rating of Perceived Exertion - Third Paired Sessions
Time frame: 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).
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.
3 secondary outcomes
Change in Heart Rate - First Paired Sessions
Time frame: Participant heart rate will be measured just prior and immediately after each intervention.
Change in Oxygen Saturation - First Paired Sessions
Time frame: Participant oxygen saturation will be measured just prior and immediately after each intervention.
Active Standing Time - First Paired Sessions
Time frame: Participant active standing time will be recorded immediately after each intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23766504Massery 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.
- Background: PubMed 31988255Roberts KJ. Enhancing Early Mobility With a Speaking Valve. Respir Care. 2020 Feb;65(2):269-270. doi: 10.4187/respcare.07671. No abstract available.
- Background: PubMed 31689414Agarwala 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.
- Background: PubMed 31615923Ceron 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.
- Individual participant dataSharing planned: No. Copies of the study protocol will be provided upon reasonable request. Requests for copies of deidentified study data will considered on a case by case basis.
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Weaning Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Cutler, DPT principal investigator
Gaylord Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Tracheostomy and PMV in place in people with PMV and Exercise Endurance, run by Gaylord Hospital, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Minute Walk Test - First Paired Sessions (time frame: 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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04941456, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.