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OpenTrials
Completed

NCT Number: NCT06025370

Pressures During Prone Positions in Healthy Volunteers

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.

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Key information

Conditions

Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Régional d'Orléans

Orléans, Centre-Val de Loire, 45067, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prone position

Other

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.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers

Acronym: HEALTHY-PRONE

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Sep 6, 2023
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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