NCT03125421

Prevention of Pressure Sores in the Prone Position in ARDS Patients

A Nursing Strategy to Prevent Pressure Sores in the Prone Position in ARDS Patients. A Multicenter Controlled Prospective Stepped Wedge Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Sores

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-04-16
• Primary completion: 2021-01-11
• Completion: 2021-01-11
• First posted: 2017-04-24
• Last updated: 2025-09-03

Locations

1 site across 1 country: France