Tracheostomy Clinical Trial
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?
Verified date | February 2024 |
Source | Gaylord Hospital, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | January 31, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 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. 2. Ability to understand and respond to simple verbal instructions and one step commands in English well enough to consent without any interpretation. 3. Ability to ambulate a minimum of 10 feet with/without assistive device and with/without physical assistance. Exclusion Criteria: 1. Active seizures 2. Active Pregnancy 3. Uncontrolled hypertension 4. Cognitive deficits that would disrupt ability to provide informed consent 5. Enteric infection control precautions 6. Ongoing orthostasis 7. Actively on decannulation protocol 8. Medical instability that would cause a doctor to put therapy program on hold |
Country | Name | City | State |
---|---|---|---|
United States | Gaylord Hospital | Wallingford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Gaylord Hospital, Inc |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Six Minute Walk Test - Session 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. | The first study session (Day 1) will occur within 72 hours of the participant being cleared by Medical Staff for PMV use. | |
Primary | Six Minute Walk Test - Session 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. | The second study session (Day 2) will occur the day following the first session (Day 1). | |
Primary | Six Minute Walk Test - Session 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. | The third study session (Day 3) will occur the day following the second session (Day 2). | |
Primary | Six Minute Walk Test - Session 4 | 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. | The fourth study session (Day 4) will occur the day following the third session (Day 3). | |
Primary | Six Minute Walk Test - Session 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. | The fifth study session (Day 5) will occur the day following the fourth session (Day 4). | |
Primary | Six Minute Walk Test - Session 6 | 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. | The sixth study session (Day 6) will occur the day following the fifth session (Day 5). | |
Primary | Average Change of Borg Rating of Perceived Exertion - Session 1 (Day 1) | 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. |
The first study session (Day 1 ) will occur within 72 hours of the participant being cleared by Medical Staff for PMV use. | |
Primary | Average Change of Borg Rating of Perceived Exertion - Session 2 (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. |
The second study session (Day 2) will occur the day following the first study session (Day 1) . | |
Primary | Average Change of Borg Rating of Perceived Exertion - Session 3 (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. |
The third study session (Day 3) will occur the day following the second study session (Day 2) . | |
Primary | Average Change of Borg Rating of Perceived Exertion - Session 4 (Day 4) | 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. |
The fourth study session (Day 4) will occur the day following the third study session (Day 3) . | |
Primary | Average change of Borg Rating of Perceived Exertion - Session 5 (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. |
The fifth study session (Day 5) will occur the day following the fourth study session (Day 4) . | |
Primary | Average Change of Borg Rating of Perceived Exertion - Session 6 (Day 6) | 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. |
The sixth study session (Day 6) will occur the day following the fifth study session (Day 5) . | |
Secondary | Heart Rate | Using a finger pulse-oxygen meter. | Participant heart rate will be measured just prior and immediately after each intervention. | |
Secondary | Oxygen Saturation | Using a finger pulse-oxygen meter. | Participant oxygen saturation will be measured just prior and immediately after each intervention. | |
Secondary | Active standing time | 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. | Participant active standing time will be recorded immediately after each intervention. |
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