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Pressures During Prone Positions in Healthy Volunteers

NCT06025370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-17

No results posted yet for this 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.

Conditions

  • Pressure Ulcer

Interventions

OTHER

Prone 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 & Collaborators

  • Centre Hospitalier Régional d'Orléans

    lead OTHER

Principal Investigators

  • Guillaume FOSSAT, Msc · CHU ORLEANS

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-04
Primary Completion
2023-10-04
Completion
2024-01-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06025370 on ClinicalTrials.gov