Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229639
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2023-12-21
Brief Title:
Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting
Sponsor:
Gaylord Hospital Inc
Organization:
Gaylord Hospital Inc
Study Overview
Official Title:
Assessing the Safety of the Nocturnal Passy Muir Valve and Its Impact on Sleep Quality in an LTACH Setting
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None