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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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