Trial Outcomes & Findings for Does Endurance Improve With the Use of Passy-Muir Valve for Patients With Tracheostomy? (NCT NCT04941456)
NCT ID: NCT04941456
Last Updated: 2025-12-11
Results Overview
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.
COMPLETED
NA
26 participants
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).
2025-12-11
Participant Flow
Eligible participants were recruited from the inpatient population admitted to Gaylord Hospital.
Patients were excluded from study inclusion if they did not meet one or more study criteria.
Participant milestones
| Measure |
Speaking Valve, Then Open Tracheostomy
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.
Open Tracheostomy: 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 place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
Open Tracheostomy, Then Speaking Valve
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.
Open Tracheostomy: 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 place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Speaking Valve, Then Open Tracheostomy
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.
Open Tracheostomy: 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 place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
Open Tracheostomy, Then Speaking Valve
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.
Open Tracheostomy: 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 place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Does Endurance Improve With the Use of Passy-Muir Valve for Patients With Tracheostomy?
Baseline characteristics by cohort
| Measure |
Open Tracheostomy, Then Speaking Valve
n=13 Participants
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.
Open Tracheostomy: 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 place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
Speaking Valve, Then Open Tracheostomy
n=13 Participants
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.
Open Tracheostomy: 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 place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=237 Participants
|
3 Participants
n=243 Participants
|
5 Participants
n=480 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=237 Participants
|
7 Participants
n=243 Participants
|
12 Participants
n=480 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=237 Participants
|
6 Participants
n=243 Participants
|
14 Participants
n=480 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=237 Participants
|
4 Participants
n=243 Participants
|
11 Participants
n=480 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=237 Participants
|
9 Participants
n=243 Participants
|
15 Participants
n=480 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
2 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
3 Participants
n=480 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=237 Participants
|
6 Participants
n=243 Participants
|
16 Participants
n=480 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=237 Participants
|
13 participants
n=243 Participants
|
26 participants
n=480 Participants
|
PRIMARY outcome
Timeframe: 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).Population: Ambulation distance (feet)
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.
Outcome measures
| Measure |
Open Tracheostomy
n=24 Participants
Open Tracheostomy: Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks.
|
Speaking Valve
n=24 Participants
Speaking valve in place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Six Minute Walk Test - First Paired Sessions
|
387 Feet
Standard Deviation 301.1
|
413 Feet
Standard Deviation 348
|
PRIMARY outcome
Timeframe: 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).Population: Complete paired datasets from sessions 3-4. This number may be less than the overall recruitment number due to discharge from hospital or study drop-out.
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.
Outcome measures
| Measure |
Open Tracheostomy
n=5 Participants
Open Tracheostomy: Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks.
|
Speaking Valve
n=5 Participants
Speaking valve in place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Six Minute Walk Test - Second Paired Sessions
|
384.6 Feet
Standard Deviation 386.61
|
350 Feet
Standard Deviation 378.81
|
PRIMARY outcome
Timeframe: 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).Population: Complete paired datasets from sessions 5-6. This number may be less than the overall recruitment number due to discharge from hospital or study drop-out.
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.
Outcome measures
| Measure |
Open Tracheostomy
n=2 Participants
Open Tracheostomy: Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks.
|
Speaking Valve
n=2 Participants
Speaking valve in place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Six Minute Walk Test - Third Paired Sessions
|
357.5 Feet
Standard Deviation 166.17
|
380 Feet
Standard Deviation 84.85
|
PRIMARY outcome
Timeframe: 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).Population: BORG change from before session to after session
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.
Outcome measures
| Measure |
Open Tracheostomy
n=23 Participants
Open Tracheostomy: Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks.
|
Speaking Valve
n=23 Participants
Speaking valve in place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Average Change of Borg Rating of Perceived Exertion - First Paired Sessions
|
3.65 Change of score on a scale
Standard Deviation 2.52
|
4.35 Change of score on a scale
Standard Deviation 2.92
|
PRIMARY outcome
Timeframe: 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).Population: Complete paired datasets from sessions 3-4. This number may be less than the overall recruitment number due to discharge from hospital or study drop-out.
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.
Outcome measures
| Measure |
Open Tracheostomy
n=5 Participants
Open Tracheostomy: Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks.
|
Speaking Valve
n=5 Participants
Speaking valve in place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Average Change of Borg Rating of Perceived Exertion - Second Paired Sessions
|
5.8 Change of score on a scale
Standard Deviation 4.82
|
6 Change of score on a scale
Standard Deviation 4.06
|
PRIMARY outcome
Timeframe: 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).Population: Complete paired datasets from sessions 5-6. This number may be less than the overall recruitment number due to discharge from hospital or study drop-out.
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.
Outcome measures
| Measure |
Open Tracheostomy
n=2 Participants
Open Tracheostomy: Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks.
|
Speaking Valve
n=2 Participants
Speaking valve in place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Average Change of Borg Rating of Perceived Exertion - Third Paired Sessions
|
8 Change of score on a scale
Standard Deviation 1.41
|
4.5 Change of score on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Participant heart rate will be measured just prior and immediately after each intervention.Population: Heart rate (BPM) change from before session to after session
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.
Outcome measures
| Measure |
Open Tracheostomy
n=24 Participants
Open Tracheostomy: Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks.
|
Speaking Valve
n=24 Participants
Speaking valve in place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Change in Heart Rate - First Paired Sessions
|
15.4 Change in beats per minute
Standard Deviation 12.4
|
18 Change in beats per minute
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: Participant oxygen saturation will be measured just prior and immediately after each intervention.Population: Oxygen Saturation (%) change from before session to after session
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.
Outcome measures
| Measure |
Open Tracheostomy
n=24 Participants
Open Tracheostomy: Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks.
|
Speaking Valve
n=24 Participants
Speaking valve in place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Change in Oxygen Saturation - First Paired Sessions
|
-2.3 Change in O2 Saturation percentage
Standard Deviation 3.9
|
-3.6 Change in O2 Saturation percentage
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Participant active standing time will be recorded immediately after each intervention.Population: Time (Seconds)
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.
Outcome measures
| Measure |
Open Tracheostomy
n=24 Participants
Open Tracheostomy: Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 1 to 3 session over approximately three-weeks.
|
Speaking Valve
n=24 Participants
Speaking valve in place: Participants will perform the six minute walk test with a PMV in place. Participants will complete 1 to 3 sessions over approximately three-weeks.
|
|---|---|---|
|
Active Standing Time - First Paired Sessions
|
257 seconds
Standard Deviation 113
|
259 seconds
Standard Deviation 110
|
Adverse Events
Speaking Valve
Open Tracheostomy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place