Pressures During Prone Positions in Healthy Volunteers (HEALTHY-PRONE)
Primary Purpose
Pressure Ulcer
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Prone Position
Sponsored by
About this trial
This is an interventional diagnostic trial for Pressure Ulcer focused on measuring Healthy Volunteer, Pressure Mapping, ARDS, Prone Position
Eligibility Criteria
Inclusion Criteria: Male or female Major volunteer Exclusion Criteria: Volunteers with cervical mobility problems preventing them from rotating their head 90° Volunteers with scapulohumeral joint mobility problems preventing them from performing 90° elevation/abduction. Pregnant volunteer (confirmed by a blood sample test or a positive pregnancy test). Volunteer not affiliated to a French social security system Volunteer protected by law
Sites / Locations
- Centre Hospitalier Régional d'Orléans
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Swimmer Position
Arms at side
Arm Description
Outcomes
Primary Outcome Measures
Skin/Bed pressures
Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)
Secondary Outcome Measures
Full Information
NCT ID
NCT06025370
First Posted
August 29, 2023
Last Updated
September 25, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
1. Study Identification
Unique Protocol Identification Number
NCT06025370
Brief Title
Pressures During Prone Positions in Healthy Volunteers
Acronym
HEALTHY-PRONE
Official Title
Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 11, 2023 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Positioning with arms alongside the body
Swimmer's 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 world's first data on the real pressures generated during PP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Healthy Volunteer, Pressure Mapping, ARDS, Prone Position
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Swimmer Position
Arm Type
Experimental
Arm Title
Arms at side
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Prone Position
Intervention Description
All healthy volunteers will be positioned in prone position, on a bed equipped with a mapping pressure system.
The volunteers will spend 5 minutes in each of the positions corresponding to the study groups.
Primary Outcome Measure Information:
Title
Skin/Bed pressures
Description
Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female
Major volunteer
Exclusion Criteria:
Volunteers with cervical mobility problems preventing them from rotating their head 90°
Volunteers with scapulohumeral joint mobility problems preventing them from performing 90° elevation/abduction.
Pregnant volunteer (confirmed by a blood sample test or a positive pregnancy test).
Volunteer not affiliated to a French social security system
Volunteer protected by law
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurelie DESPUJOLS
Phone
0238744071
Ext
+33
Email
aurelie.despujols@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume FOSSAT, Msc
Organizational Affiliation
CHU ORLEANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Régional d'Orléans
City
Orléans
State/Province
Centre Val De Loire
ZIP/Postal Code
45067
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pressures During Prone Positions in Healthy Volunteers
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