Pressures During Prone Positions in Healthy Volunteers

NCT06025370 | Completed

• 1 other identifier: CHRO-2022-13
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Positioning with arms alongside the body
2. 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.

Conditions

Pressure Ulcer

Keywords

Healthy Volunteer; Pressure Mapping; ARDS; Prone Position

Outcome Measures

Primary Outcomes (1)

• Skin/Bed pressures

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

  5 minutes

Study Arms (2)

Swimmer Position

EXPERIMENTAL

Other: Prone Position

Arms at side

ACTIVE COMPARATOR

Other: Prone Position

Interventions

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.

Arms at side; Swimmer Position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Major volunteer

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Centre Hospitalier Régional d'Orléans

Orléans, Centre-Val de Loire, 45067, France

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Guillaume FOSSAT, Msc

  CHU ORLEANS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: October 4, 2023
• Primary Completion: October 4, 2023
• Study Completion: January 4, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)