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

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ClinicalTrials.gov Identifier: NCT03125421
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pressure Sores Procedure: standard preventive methods of pressure sores Procedure: experimental multifaceted preventive methods of pressure sores Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Nursing Strategy to Prevent Pressure Sores in the Prone Position in ARDS Patients. A Multicenter Controlled Prospective Stepped Wedge Trial
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : January 16, 2021
Estimated Study Completion Date : January 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
control period
standard preventive methods of pressure sores in each center
Procedure: standard preventive methods of pressure sores

During the control period, the following specific methods to prevent pressure sores in the prone position (in ARDS patients mechanically ventilated via tracheal route) will be these ongoing in each center and involve the following components: lower eyelid and ocular protection by any method, inclination of the body from the horizontal position, intermittent head mobilization to the right or to the left, and no use of specific device to prevent pressures sores at the head and/or thorax, and/or knees, and/or feet.

The following nonspecific methods to prevent pressures sores will be performed at the discretion of each center according to its usual practice: mattress, upper eyelid protection, main devices securely fasten, arms position, abdomen supported or not, mouth care, enteral nutrition continued in the prone position, skin protection and/or massage.


Experimental: experimental period
experimental multifaceted preventive methods of pressure sores
Procedure: experimental multifaceted preventive methods of pressure sores

During the experimental period, the following specific methods to prevent pressure sores in the prone position (in ARDS patients mechanically ventilated via tracheal route) will be systematically applied: lower eyelid protection by horizontal strap, ocular protection by methylcellulose, 15° inclination of the body from the horizontal position, intermittent head mobilization to the right or to the left every four hours, and use of specific device to prevent pressures sores at the head, thorax, knees, and feet.

The following nonspecific methods to prevent pressures sores will be applied as in the control period described above except for the following: the abdomen will not be supported and the skin will not be protected.





Primary Outcome Measures :
  1. number of patients with a new pressure sore of any stage in any predetermined location [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125421


Contacts
Contact: Lucile Gay 4 26 10 92 65 ext +33 lucile.gay@chu-lyon.fr
Contact: Claude GUERIN +33 4 26 10 92 78 claude.guerin@chu-lyon.fr

Locations
France
Hospices Civils de Lyon - Hopital Croix Rousse Recruiting
Lyon, France, 69004
Contact: Lucile Gay    4 26 10 92 65 ext +33    lucile.gay@chu-lyon.fr   
Contact: Claude GUERIN    +33 4 26 10 92 78    claude.guerin@chu-lyon.fr   
Principal Investigator: Lucile Gay         
Principal Investigator: Claude GUERIN         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Lucile Gay Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03125421     History of Changes
Other Study ID Numbers: 69HCL17_0039
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases