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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participant heart rate will be measured just prior and immediately after each intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica Cutler, DPT | Gaylord Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaylord Hospital | Wallingford | Connecticut | 06492 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23766504 | Background | 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. | |
| 31988255 | 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. |
| Label | URL |
|---|---|
| Borg Rating of Perceived Exertion; Physio-Pedia | View source |
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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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Patients were excluded from study inclusion if they did not meet one or more study criteria.
Eligible participants were recruited from the inpatient population admitted to Gaylord Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age at time of study consent and enrollment is reported. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Ambulation distance (feet) | Posted | Mean | Standard Deviation | Feet | 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). |
Participants were assessed for adverse events during the course of enrollment in study activities, on average 1 month from baseline.
The definition of adverse event and/or serious adverse event did not differs from the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Speaking Valve | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Henry Hrdlicka | Gaylord Hospital, Inc. | 203-284-2864 | hhrdlicka@gaylord.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2024 | Nov 12, 2025 | Prot_SAP_000.pdf |
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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.
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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.
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|
| 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. |
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| 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). |
| 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. |
| 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. | Participant active standing time will be recorded immediately after each intervention. |
| 31689414 | 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. |
| 31615923 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Speaking Valve | 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. |
| OG001 | Open Tracheostomy | 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. |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Feet | 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). |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Feet | 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). |
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| Primary | 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. | BORG change from before session to after session | Posted | Mean | Standard Deviation | Change of score on a scale | 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). |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Change of score on a scale | 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). |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Change of score on a scale | 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). |
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| Secondary | 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. | Heart rate (BPM) change from before session to after session | Posted | Mean | Standard Deviation | Change in beats per minute | Participant heart rate will be measured just prior and immediately after each intervention. |
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| Secondary | 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. | Oxygen Saturation (%) change from before session to after session | Posted | Mean | Standard Deviation | Change in O2 Saturation percentage | Participant oxygen saturation will be measured just prior and immediately after each intervention. |
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| Secondary | 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 (Seconds) | Posted | Mean | Standard Deviation | seconds | Participant active standing time will be recorded immediately after each intervention. |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Open Tracheostomy | 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. | 0 | 13 | 0 | 13 | 0 | 13 |
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