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?
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02116608 -
Treatment of Tracheostomy Granulomas
|
Phase 4 | |
Not yet recruiting |
NCT06375369 -
Digital Health Pathway for Children With Medical Complexity Requiring Tracheostomy
|
N/A | |
Completed |
NCT01976819 -
Clinical Assessment of New Speaking Valve With Heat and Moisture Exchanger (HME) for Tracheotomized Patients
|
N/A | |
Terminated |
NCT00323986 -
Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy
|
Phase 2 | |
Not yet recruiting |
NCT06236542 -
Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety
|
N/A | |
Completed |
NCT03955874 -
Mechanical Ventilation Discontinuation Practices
|
||
Completed |
NCT04668742 -
Efficacy and Safety of the DYNAtraq Device to Prevent Complications in Tracheostomy in Mechanically Ventilated Patients
|
N/A | |
Recruiting |
NCT05047432 -
Concordance of Methods to Select Tracheostomy Tube Size for Adults in Intensive Care
|
||
Recruiting |
NCT06120790 -
Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
|
||
Withdrawn |
NCT05658029 -
An Investigator-initiated Study to Evaluate Safety and Efficacy of ARINA-1 in People With a Tracheostomy
|
Phase 1 | |
Active, not recruiting |
NCT05041894 -
Effect of Body Tilting on Diaphragm Excursion and Thickness in the Stroke Patients With Tracheotomy by Ultrasonography
|
||
Active, not recruiting |
NCT02990871 -
Efficacy of an Early Rehabilitation on Decannulation Time of Patients With Severe Acquired Brain Injury
|
N/A | |
Enrolling by invitation |
NCT06283953 -
Boosting Resources for Tracheostomy Care at Home
|
N/A | |
Not yet recruiting |
NCT04872881 -
Comparison of Effectiveness of Different Airway Management Methods During Percutaneous Tracheostomy
|
Phase 4 | |
Completed |
NCT02512744 -
Reducing Decannulation Time: Limitation of Decannulation Capping Trials (REDECAP)
|
N/A | |
Recruiting |
NCT04642703 -
Mortality in Patients With Severe COVID-19 Pneumonia Who Underwent Tracheostomy
|
||
Completed |
NCT04447638 -
Percutaneous Tracheostomy With COVID-19
|
||
Completed |
NCT05434442 -
Caregivers Tracheal Aspiration Training
|
N/A | |
Not yet recruiting |
NCT06431048 -
No DIET Trial: Dogmatic Interruption of Enteral nuTrition
|
N/A | |
Recruiting |
NCT02469909 -
Comparison Between Immediate and Gradual Decannulation
|
N/A |