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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06025370
Other study ID # CHRO-2022-13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2023
Est. completion date January 4, 2024

Study information

Verified date January 2024
Source Centre Hospitalier Régional d'Orléans
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 4, 2024
Est. primary completion date October 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Centre Hospitalier Régional d'Orléans Orléans Centre Val De Loire

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skin/Bed pressures Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet) 5 minutes
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