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
|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|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Contact: Lucile Gay||4 26 10 92 65 ext +email@example.com|
|Contact: Claude GUERIN||+33 4 26 10 92 firstname.lastname@example.org|
|Hospices Civils de Lyon - Hopital Croix Rousse||Recruiting|
|Lyon, France, 69004|
|Contact: Lucile Gay 4 26 10 92 65 ext +33 email@example.com|
|Contact: Claude GUERIN +33 4 26 10 92 78 firstname.lastname@example.org|
|Principal Investigator: Lucile Gay|
|Principal Investigator: Claude GUERIN|
|Principal Investigator:||Lucile Gay||Hospices Civils de Lyon|