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

Tracheostomy Clinical Trial

Official title:
Assessing the Safety of the Nocturnal Passy Muir Valve and Its Impact on Sleep Quality in an LTACH Setting

Clinical Trial 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.

Clinical Trial 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 evidence is needed to demonstrate the safety of nocturnal PMV use before larger studies can be conducted. It was anecdotally witnessed that patients frequently sleep during the day with the PMV in place, suffering no recourse to adverse events. The primary objective of this study was to determine if nocturnal PMV use can be considered safe within the long-term acute care hospital setting and its impact on sleep quality ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06229639
Study type Interventional
Source Gaylord Hospital, Inc
Contact
Status Completed
Phase N/A
Start date January 2016
Completion date February 2018
View Details
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