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Pressures During Prone Positions in Healthy Volunteers

Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06025370
Acronym
HEALTHY-PRONE
Enrollment
30
Registered
2023-09-06
Start date
2023-10-04
Completion date
2024-01-04
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcer

Keywords

Healthy Volunteer, Pressure Mapping, ARDS, Prone Position

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.

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.

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Skin/Bed pressures5 minutesObtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026