Prevention of Pressure Sores in the Prone Position in ARDS Patients

Not Applicable

Completed

• Conditions: Pressure Sores
• Interventions: Procedure: standard preventive methods of pressure sores; Procedure: experimental multifaceted preventive methods of pressure sores

• Registration Number: NCT03125421
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

A nursing strategy to prevent pressure sores in the prone position in Acute Respiratory Distress Syndrome (ARDS) patients. A multicenter controlled prospective stepped wedge trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-24
• Study Start: 2018-04-16
• Primary Completion: 2021-01-11
• Study Completion: 2021-01-11
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 18 years or more in age
• staying in Intensive Care Unit (ICU)
• Intubated
• mechanically ventilated
• severe ARDS defined as arterial Pressure in Oxygen (PaO2)/ Oxygen Inspired Fraction (FIO2) < 150 mmHg with positive end-expiratory pressure (PEEP) ≥ 5 cmH2O and FIO2 ≥ 0.60
• prone positioning indicated by the clinician in charge
• weight < 140 kgs
• agreement to participate obtained from the confidence person of the patient
• affiliated to social protection insurance

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Exclusion Criteria

• contra-indication to the prone positioning
• prone positioning before inclusion
• person under legal protection
• pregnancy
• weight > 140 kg
• tracheotomy
• extracorporeal membrane oxygenation (ECMO)
• Refusal to participate

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
control period	standard preventive methods of pressure sores	standard preventive methods of pressure sores in each center
experimental period	experimental multifaceted preventive methods of pressure sores	experimental multifaceted preventive methods of pressure sores

Primary Outcome Measures

Name	Time	Method
number of patients with a new pressure sore of any stage in any predetermined location	day 7 after inclusion	New pressure sores are validated by the independent committee (2 persons) in charge of the analysis of the pictures performed in the patients. The whole body is pictured in 3 parts and specific locations will be analyzed, which are forehead, nose, eyes, chin, jaw, lips, thorax, breast, knee, iliac crest, foot extension area, and external genitalia in man. For each location a four-stage severity score of the pressure sore is assessed.

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hopital Croix Rousse; 🇫🇷 Lyon, France