Pressure Sores
Conditions
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.
Interventions
PROCEDUREstandard 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.
PROCEDUREexperimental 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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with a new pressure sore of any stage in any predetermined location | 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLucile Gay
Hospices Civils de Lyon
Outcome results
None listed