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

Primary Purpose

Pressure Sores

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
standard preventive methods of pressure sores
experimental multifaceted preventive methods of pressure sores
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Sores

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospices Civils de Lyon - Hopital Croix Rousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control period

experimental period

Arm Description

standard preventive methods of pressure sores in each center

experimental multifaceted preventive methods of pressure sores

Outcomes

Primary Outcome Measures

number of patients with a new pressure sore of any stage in any predetermined location
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.

Secondary Outcome Measures

Full Information

First Posted
April 19, 2017
Last Updated
May 3, 2021
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03125421
Brief Title
Prevention of Pressure Sores in the Prone Position in ARDS Patients
Acronym
PSA
Official Title
A Nursing Strategy to Prevent Pressure Sores in the Prone Position in ARDS Patients. A Multicenter Controlled Prospective Stepped Wedge Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
January 11, 2021 (Actual)
Study Completion Date
January 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Sores

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control period
Arm Type
Other
Arm Description
standard preventive methods of pressure sores in each center
Arm Title
experimental period
Arm Type
Experimental
Arm Description
experimental multifaceted preventive methods of pressure sores
Intervention Type
Procedure
Intervention Name(s)
standard preventive methods of pressure sores
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
experimental multifaceted preventive methods of pressure sores
Intervention Description
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 Measure Information:
Title
number of patients with a new pressure sore of any stage in any predetermined location
Description
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.
Time Frame
day 7 after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucile Gay
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon - Hopital Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

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Prevention of Pressure Sores in the Prone Position in ARDS Patients

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