Does Endurance Improve With the Use of Passy-Muir Valve for Patients With Tracheostomy?

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tracheostomy; PMV; Exercise Endurance
• Intervention / Treatment: Other: Open Tracheostomy; Device: PMV in place

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Wallingford, Connecticut, United States, 06492
      • Gaylord Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open Tracheostomy; Participants will perform the six-minute walk test each session to assess ambulation distance, alternating between the open tracheostomy (standard) versus the Passy-Muir Valve in place intervention on sequential days to compare results.	Other: 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.; Other Names: Standard
Experimental: PMV in place; Participants will perform the six-minute walk test each session to assess ambulation distance, alternating between the open tracheostomy (standard) versus the Passy-Muir Valve in place intervention on sequential days to compare results.	Device: 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.; Other Names: PMV; Passy-Muir Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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).
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).
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).
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).
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).
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.
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) .
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) .
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) .
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) .
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Using a finger pulse-oxygen meter.	Participant heart rate will be measured just prior and immediately after each intervention.
Oxygen Saturation	Using a finger pulse-oxygen meter.	Participant oxygen saturation will be measured just prior and immediately after each intervention.
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.

Collaborators and Investigators

• Sponsor: Gaylord Hospital, Inc
• Investigators: Principal Investigator: Erica Cutler, DPT, Gaylord Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Borg Rating of Perceived Exertion; Physio-Pedia
• Six Minute Walk Test / 6 Minute Walk Test; Physio-Pedia
• Centers for Disease Control and Prevention. Perceived Exertion

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Tracheostomy; Oxygen Saturation; Six minute walk test; PMV; Passy Muir Valve; Activity Tolerance; Intra-Thoracic Pressure; Borg Rating of Perceived Exertion
• Other Study ID Numbers: 202104CUT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Copies of the study protocol will be provided upon request. Requests for copies of deidentified study data will considered on a case by case basis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes