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CompletedNCT06025370HEALTHY-PRONEUpdated Jan 17, 2024

Pressures During Prone Positions in Healthy Volunteers

An interventional study of Prone Position in Pressure Ulcer, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-17.

Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pressure Ulcer

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Keywords

  • Healthy Volunteer
  • Pressure Mapping
  • ARDS
  • Prone Position
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's enrollment of 30 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Centre Hospitalier Régional d'Orléans is the lead sponsor of 129 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or female
  • Major volunteer

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Swimmer Position

    Other: Prone Position

  • Active comparator
    Arms at side

    Other: Prone Position

Interventions

  • OtherProne 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.

06

What researchers measure

Primary outcomes

  1. Skin/Bed pressures

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

    Time frame: 5 minutes

07

Study locations

1 site
  • Centre Hospitalier Régional d'Orléans
    Orléans, Centre Val De Loire 45067, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06025370
Lead sponsor
Centre Hospitalier Régional d'Orléans
Responsible party
Sponsor
First posted
Sep 6, 2023
Start date
Oct 4, 2023
Primary completion
Oct 4, 2023
Completion
Jan 4, 2024
Last update
Jan 17, 2024

Study contacts

Guillaume FOSSAT, Msc
principal investigator · CHU ORLEANS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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