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Pressures During Prone Positions in Healthy Volunteers (HEALTHY-PRONE)

C

Centre Hospitalier Régional d'Orléans

Status

Completed

Conditions

Pressure Ulcer

Treatments

Other: Prone Position

Study type

Interventional

Funder types

Other

Identifiers

NCT06025370
CHRO-2022-13

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Swimmer Position
Experimental group
Treatment:
Other: Prone Position
Arms at side
Active Comparator group
Treatment:
Other: Prone Position

Trial contacts and locations

1

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Central trial contact

Aurelie DESPUJOLS

Data sourced from clinicaltrials.gov

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