Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting
Completed · Not applicable
Conditions studied: Tracheostomy
In brief
Limited research has been done to assess the safety of PMV use during sleep. One prospective study completed by Diez-Gross, et al in 2007 looked at 10 male subjects recorded on two consecutive nights, one night with PMV on and one night with PMV off. All recordings took place in a monitored setting. The variables studied included O2 saturation, apnea index, apnea - hypopnea index, and nursing reports. Conclusion was PMV use for one night in seriously ill tracheostomy patients was not associated with respiratory distress or cardiac issues.
Key facts
- Study ID
- NCT06229639
- Run by
- Gaylord Hospital, Inc
- People needed
- 33
- Starts
- 2016-01-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient has evidence of respiratory insufficiency requiring a tracheostomy tube without current need for assisted ventilation.
- Patient will be continuously monitored with telemetry.
- Patient satisfies criteria for the decannulation protocol and agrees to use the Passy Muir Valve during sleep.
- Patient is able to follow directions following speech/language/cognitive evaluation or screening completed by the Speech-Language Pathologist and physician assessment.
- Patient is at least 18 years old.
- An informed consent is signed by patient or Power of Attorney (POA).
- Patient is able to tolerate the PMV during the day for a minimum of 6 continuous hours
- Patient has a maximum size #6 Shiley cuffless tracheostomy tube or equivalent.
You may not qualify if…
- Patient identified at time of admission as requiring invasive long-term assisted ventilation.
- Patient with documented or suspected upper airway obstruction and/or surgery or permanent tracheostomy tube.
- Patient is quadriplegic (due to the inability for a quadriplegic patient to manually self-remove the valve in case of emergency).
- Patient or POA failed to sign consent.
- Pt has a severe cognitive impairment as determined by a formal cognitive-linguistic evaluation by a licensed Speech Language Pathologist.
- Patient unable to meet criteria for decannulation protocol or has failed decannulation protocol within last two weeks.
Where it is running
- Gaylord Hospital — Wallingford, Connecticut, United States
Full record on ClinicalTrials.gov
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