Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting (NCT06229639) | Clinical Trial Compass
CompletedNot Applicable
Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting
United States33 participantsStarted 2016-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Heart Rate
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
2
Systolic Blood Pressure
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
3
Diastolic Blood Pressure
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
4
Body Temperature
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
5
O2
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
6
ETCO2
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00
7
Respiratory Rate
Timeframe: Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00