Does Endurance Improve With the Use of Passy-Muir Valve for Patients With Tracheostomy?
Launched by GAYLORD HOSPITAL, INC · Jun 24, 2021
Trial Information
Current as of July 23, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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 peri...
Gender
ALL
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
About Gaylord Hospital, Inc
Gaylord Hospital, Inc. is a leading healthcare institution dedicated to providing specialized rehabilitation services and innovative clinical trials aimed at improving patient outcomes. With a commitment to excellence in patient care and research, Gaylord Hospital leverages its state-of-the-art facilities and multidisciplinary expertise to explore new therapeutic interventions and enhance the quality of life for individuals with complex medical conditions. The organization fosters a collaborative environment that prioritizes safety, ethical standards, and patient-centered approaches in all clinical research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Wallingford, Connecticut, United States
Patients applied
Trial Officials
Erica Cutler, DPT
Principal Investigator
Gaylord Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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