Clinical trial NCT04941456: Does Endurance Improve With the Use of Passy-Muir Valve for Patients With Tracheostomy?
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?
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: PMV
Exercise Endurance
Tracheostomy
Keywords: Tracheostomy
PMV
Passy Muir Valve
Activity Tolerance
Intra-Thoracic Pressure
Six minute walk test
Borg Rating of Perceived Exertion
Oxygen Saturation
Lead sponsor: Gaylord Hospital, Inc
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Six Minute Walk Test - Session 1
timeFrame: The first study session (Day 1) will occur within 72 hours of the participant being cleared by Medical Staff for PMV use.
measure: Six Minute Walk Test - Session 2
timeFrame: The second study session (Day 2) will occur the day following the first session (Day 1).
measure: Six Minute Walk Test - Session 3
timeFrame: The third study session (Day 3) will occur the day following the second session (Day 2).
measure: Six Minute Walk Test - Session 4
timeFrame: The fourth study session (Day 4) will occur the day following the third session (Day 3).
measure: Six Minute Walk Test - Session 5
timeFrame: The fifth study session (Day 5) will occur the day following the fourth session (Day 4).
measure: Six Minute Walk Test - Session 6
timeFrame: The sixth study session (Day 6) will occur the day following the fifth session (Day 5).
measure: Average Change of Borg Rating of Perceived Exertion - Session 1 (Day 1)
timeFrame: The first study session (Day 1 ) will occur within 72 hours of the participant being cleared by Medical Staff for PMV use.
measure: Average Change of Borg Rating of Perceived Exertion - Session 2 (Day 2)
timeFrame: The second study session (Day 2) will occur the day following the first study session (Day 1) .
measure: Average Change of Borg Rating of Perceived Exertion - Session 3 (Day 3)
timeFrame: The third study session (Day 3) will occur the day following the second study session (Day 2) .
measure: Average Change of Borg Rating of Perceived Exertion - Session 4 (Day 4)
timeFrame: The fourth study session (Day 4) will occur the day following the third study session (Day 3) .
measure: Average change of Borg Rating of Perceived Exertion - Session 5 (Day 5)
timeFrame: The fifth study session (Day 5) will occur the day following the fourth study session (Day 4) .
measure: Average Change of Borg Rating of Perceived Exertion - Session 6 (Day 6)
timeFrame: The sixth study session (Day 6) will occur the day following the fifth study session (Day 5) .
Secondary outcomes:
measure: Heart Rate
timeFrame: Participant heart rate will be measured just prior and immediately after each intervention.
measure: Oxygen Saturation
timeFrame: Participant oxygen saturation will be measured just prior and immediately after each intervention.
measure: Active standing time
timeFrame: Participant active standing time will be recorded immediately after each intervention.
Other outcomes:
Locations:
city: Wallingford
country: United States
facility: Gaylord Hospital
state: Connecticut
Study officials:
affiliation: Gaylord Hospital
name: Erica Cutler, DPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.