Pressures During Prone Positions in Healthy Volunteers

Pressure Ulcer Clinical Trial

— HEALTHY-PRONE  

Official title:

Measurement of Pressures Generated During Different Prone Positions in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06025370
• Other study ID #: CHRO-2022-13
• Status: Completed
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: January 4, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 4, 2024
• Est. primary completion date: October 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Régional d'Orléans	Orléans	Centre Val De Loire

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin/Bed pressures	Obtain pressure values for both prone position techniques on pressure sore risk zones (face/shoulders/hips/knees/feet)	5 minutes