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Clinical Trials/NCT06025370
NCT06025370
Completed
Not Applicable

Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers

Centre Hospitalier Régional d'Orléans1 site in 1 country30 target enrollmentOctober 4, 2023
ConditionsPressure Ulcer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pressure Ulcer
Sponsor
Centre Hospitalier Régional d'Orléans
Enrollment
30
Locations
1
Primary Endpoint
Skin/Bed pressures
Status
Completed
Last Updated
2 years ago

Overview

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. 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.

Registry
clinicaltrials.gov
Start Date
October 4, 2023
End Date
January 4, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Skin/Bed pressures

Time Frame: 5 minutes

Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)

Study Sites (1)

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