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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control period | Other | standard preventive methods of pressure sores in each center |
|
| experimental period | Experimental | experimental multifaceted preventive methods of pressure sores |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard preventive methods of pressure sores | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 7 after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucile Gay | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hopital Croix Rousse | Lyon | 69004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40509643 | Result | Gay L, Huot L, Yonis H, Valera S, Hraeich S, Matthieu D, Gacouin A, Ouisse C, Reignier J, Massard A, Quenot JP, Revol C, Robine A, Guillemault O, Bourdin G, Robert A, Lacherade JC, Perarder C, Badet M, Baboi L, Rabilloud M, Decullier E, Montagne E, Girard R, Arcuset C, Mevel J, de Montigny AM, Guerin C. A Bundle of Interventions to Prevent Pressure Ulcers During Prone Position in Adult Patients With Acute Respiratory Distress Syndrome: Results of a French Stepped-Wedge Randomized Controlled Trial. Nurs Crit Care. 2025 Jul;30(4):e70084. doi: 10.1111/nicc.70084. |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| experimental multifaceted preventive methods of pressure sores | Procedure | 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. |
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