Search / Trial NCT06229639

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 October 08, 2024

Completed

Keywords

Tracheostomy Speaking Valve Sleep Quality Ltach Passy Muir Valve Respiratory Care

Description

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.

Locations

Wallingford, Connecticut, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0