HEALTHY-PRONE: Pressures During Prone Positions in Healthy Volunteers

Sponsor

Centre Hospitalier Régional d'Orléans (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06025370

Collaborator

(none)

Enrollment

Location

Arms

4.7

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Prone positioning (PP) reduces mortality in the most severe cases of acute respiratory distress syndrome (ARDS) (GUERIN NEJM 2013). 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 (SUD, ICM, 2010).

There are 2 PP techniques:

Positioning with arms alongside the body
Swimmer's position At present, no study compares or has compared (medline source, October 2022) 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. We 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.

We would like to use our device to measure pressures during these 2 PP in healthy volunteers, which would enable us to obtain the world's first data on the real pressures generated during PP.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer	Other: Prone Position	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers

Anticipated Study Start Date :

Sep 11, 2023

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Swimmer Position	Other: Prone Position 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.
Active Comparator: Arms at side	Other: Prone Position 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.

Arm

Intervention/Treatment

Experimental: Swimmer Position

Other: Prone Position

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.

Active Comparator: Arms at side

Other: Prone Position

Outcome Measures

Primary Outcome Measures

Skin/Bed pressures [5 minutes]
Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Régional d'Orléans	Orléans	Centre Val De Loire	France	45067

Sponsors and Collaborators

Centre Hospitalier Régional d'Orléans

Investigators

Principal Investigator: Guillaume FOSSAT, Msc, CHU ORLEANS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Régional d'Orléans

ClinicalTrials.gov Identifier:

NCT06025370

Other Study ID Numbers:

CHRO-2022-13

First Posted:

Sep 6, 2023

Last Update Posted:

Sep 6, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Régional d'Orléans

Additional relevant MeSH terms:

Pressure Ulcer

Study Results

No Results Posted as of Sep 6, 2023