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Clinical Trials/NCT06025370
NCT06025370CompletedNot Applicable

Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers

Centre Hospitalier Régional d'Orléans1 site in 1 country30 target enrollmentStarted: October 4, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Skin/Bed pressures

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Arms at side

Active Comparator

Intervention: Prone Position (Other)

Swimmer Position

Experimental

Intervention: Prone Position (Other)

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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