Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting
Launched by GAYLORD HOSPITAL, INC · Jan 19, 2024
Trial Information
Current as of May 08, 2025
Completed
Keywords
ClinConnect Summary
Currently, the PMV has only been approved by the FDA for daytime use. As such, it is encouraged to remove speaking valves at night. However, there is minimal evidence indicating that the use of speaking valves during nighttime poses a significant risk. Studies focusing on the safety of the PMV for nocturnal use reported no significant effects on patients' well-being, including no significant oxygen desaturations or major cardiopulmonary events. This was shown in pediatric patients and adult patients admitted to an ICU. While promising, these findings are still limited, and additional eviden...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Patient has evidence of respiratory insufficiency requiring a tracheostomy tube without current need for assisted ventilation.
- • 2. Patient will be continuously monitored with telemetry.
- • 3. Patient satisfies criteria for the decannulation protocol and agrees to use the Passy Muir Valve during sleep.
- • 4. Patient is able to follow directions following speech/language/cognitive evaluation or screening completed by the Speech-Language Pathologist and physician assessment.
- • 5. Patient is at least 18 years old.
- • 6. An informed consent is signed by patient or Power of Attorney (POA).
- • 7. Patient is able to tolerate the PMV during the day for a minimum of 6 continuous hours
- • 8. Patient has a maximum size #6 Shiley cuffless tracheostomy tube or equivalent.
- Exclusion Criteria:
- • 1. Patient identified at time of admission as requiring invasive long-term assisted ventilation.
- • 2. Patient with documented or suspected upper airway obstruction and/or surgery or permanent tracheostomy tube.
- • 3. Patient is quadriplegic (due to the inability for a quadriplegic patient to manually self-remove the valve in case of emergency).
- • 4. Patient or POA failed to sign consent.
- • 5. Pt has a severe cognitive impairment as determined by a formal cognitive-linguistic evaluation by a licensed Speech Language Pathologist.
- • 6. Patient unable to meet criteria for decannulation protocol or has failed decannulation protocol within last two weeks.
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported