N/A N=30 Other

Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting

Tracheostomy

Bottom Line

View on ClinicalTrials.gov: NCT06229639 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Heart Rate — 84.10; 84.33 beats per minute — p=0.87

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Passy Muir Valve (Device); Tracheostomy Plug (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gaylord Hospital, Inc
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Heart Rate	84.10; 84.33	0.87
PRIMARY Systolic Blood Pressure	124.6; 127.6	0.18
PRIMARY Diastolic Blood Pressure	70.73; 73.46	0.02 sig
PRIMARY Body Temperature	98.08; 98.05	0.64
PRIMARY O2	96.29; 96.37	0.86
PRIMARY ETCO2	37.14; 36.08	0.11
PRIMARY Respiratory Rate	18.36; 18.37	0.98
SECONDARY pH	7.452; 7.439	0.20
SECONDARY PCO2	43.07; 44.86	0.16
SECONDARY PO2	74.91; 79.69	0.25
SECONDARY Bicarbonate	32.41; 30.38	0.37
SECONDARY Sleep Quality	65.19; 66.78	—
SECONDARY Richard Campbell Sleep Questionnaire	65.19; 66.78	0.67

Summary

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06229639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.