An interventional study of Open Tracheostomy and PMV in place in PMV, Exercise Endurance and Tracheostomy, sponsored by Gaylord Hospital, Inc. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by Gaylord Hospital, Inc · Not applicable, Interventional, and Treatment
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.
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.
Gaylord Hospital, Inc is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: Participant active standing time will be recorded immediately after each intervention.
Eligible participants were recruited from the inpatient population admitted to Gaylord Hospital.
| Milestone | Speaking Valve, Then Open Tracheostomy | Open Tracheostomy, Then Speaking Valve |
|---|---|---|
| Started | 13 | 13 |
| Completed | 11 | 13 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
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.
| Feet | Speaking Valve | Open Tracheostomy |
|---|---|---|
| Six Minute Walk Test - First Paired Sessions | 413 ± 348 | 387 ± 301.1 |
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.
| Feet | Speaking Valve | Open Tracheostomy |
|---|---|---|
| Six Minute Walk Test - Second Paired Sessions | 350 ± 378.81 | 384.6 ± 386.61 |
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.
| Feet | Speaking Valve | Open Tracheostomy |
|---|---|---|
| Six Minute Walk Test - Third Paired Sessions | 380 ± 84.85 | 357.5 ± 166.17 |
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.
| Change of score on a scale | Speaking Valve | Open Tracheostomy |
|---|---|---|
| Average Change of Borg Rating of Perceived Exertion - First Paired Sessions | 4.35 ± 2.92 | 3.65 ± 2.52 |
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.
| Change of score on a scale | Speaking Valve | Open Tracheostomy |
|---|---|---|
| Average Change of Borg Rating of Perceived Exertion - Second Paired Sessions | 6 ± 4.06 | 5.8 ± 4.82 |
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.
| Change of score on a scale | Speaking Valve | Open Tracheostomy |
|---|---|---|
| Average Change of Borg Rating of Perceived Exertion - Third Paired Sessions | 4.5 ± 0.71 | 8 ± 1.41 |
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.
| Change in beats per minute | Speaking Valve | Open Tracheostomy |
|---|---|---|
| Change in Heart Rate - First Paired Sessions | 18 ± 12.5 | 15.4 ± 12.4 |
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.
| Change in O2 Saturation percentage | Speaking Valve | Open Tracheostomy |
|---|---|---|
| Change in Oxygen Saturation - First Paired Sessions | -3.6 ± 4.3 | -2.3 ± 3.9 |
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.
| seconds | Speaking Valve | Open Tracheostomy |
|---|---|---|
| Active Standing Time - First Paired Sessions | 259 ± 110 | 257 ± 113 |
Collected over Participants were assessed for adverse events during the course of enrollment in study activities, on average 1 month from baseline.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Speaking Valve | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Open Tracheostomy | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Categorical(Participants) | Open Tracheostomy, Then Speaking Valve | Speaking Valve, Then Open Tracheostomy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 7 | 12 |
| >=65 years | 8 | 6 | 14 |
| Sex: Female, Male(Participants) | Open Tracheostomy, Then Speaking Valve | Speaking Valve, Then Open Tracheostomy | Total |
|---|---|---|---|
| Female | 7 | 4 | 11 |
| Male | 6 | 9 | 15 |
| Race (NIH/OMB)(Participants) | Open Tracheostomy, Then Speaking Valve | Speaking Valve, Then Open Tracheostomy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 10 | 6 | 16 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Region of Enrollment(participants) | Open Tracheostomy, Then Speaking Valve | Speaking Valve, Then Open Tracheostomy | Total |
|---|---|---|---|
| United States | 13 | 13 | 26 |
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