Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06025370
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2023-08-29
Brief Title:
Pressures During Prone Positions in Healthy Volunteers
Sponsor:
Centre Hospitalier Régional dOrléans
Organization:
Centre Hospitalier Régional dOrléans
Study Overview
Official Title:
Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers
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:
HEALTHY-PRONE
Brief Summary:
Prone positioning PP reduces mortality in the most severe cases of acute respiratory distress syndrome ARDS Despite the benefits of PP this technique presents adverse effects such as an increased risk of bedsores linked to the duration which must be around 16 consecutive hours
There are 2 PP techniques
1 Positioning with arms alongside the body
2 Swimmers position At present no study compares or has compared prospectively the impact of the type of position used during ventral decubitus on mortality and the incidence of pressure sores nor on secondary effects in intensive care
Pressure transducers are available for instantaneous measurement of pressures between 2 interfaces The investigators have acquired a pressure-measuring device a mattress topper which is attached to the resuscitation mattress and which connected to a PC provides a live display of the pressures between the patient and the mattress
The investigators would like to use their device to measure pressures during these 2 PP in healthy volunteers which would enable them to obtain the worlds first data on the real pressures generated during PP
There are 2 PP techniques
1 Positioning with arms alongside the body
2 Swimmers position At present no study compares or has compared prospectively the impact of the type of position used during ventral decubitus on mortality and the incidence of pressure sores nor on secondary effects in intensive care
Pressure transducers are available for instantaneous measurement of pressures between 2 interfaces The investigators have acquired a pressure-measuring device a mattress topper which is attached to the resuscitation mattress and which connected to a PC provides a live display of the pressures between the patient and the mattress
The investigators would like to use their device to measure pressures during these 2 PP in healthy volunteers which would enable them to obtain the worlds first data on the real pressures generated during PP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None