Prevention of Pressure Sores in the Prone Position in ARDS Patients (PSA)

Civil Hospices of Lyon

Status: Completed

Conditions: Pressure Sores

Treatments: Procedure: experimental multifaceted preventive methods of pressure sores; Procedure: standard preventive methods of pressure sores

Study type: Interventional

Funder types: Other

Identifiers

NCT03125421

69HCL17_0039

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

control period

Other group

Description:

standard preventive methods of pressure sores in each center

Treatment:

Procedure: standard preventive methods of pressure sores

experimental period

Experimental group

Description:

experimental multifaceted preventive methods of pressure sores

Treatment:

Procedure: experimental multifaceted preventive methods of pressure sores