Prevention of Pressure Sores in the Prone Position in ARDS Patients

Pressure Sores Clinical Trial

— PSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125421
• Other study ID #: 69HCL17_0039
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: January 11, 2021

Study information

• Verified date: May 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Sores
• Pressure Ulcer

Intervention

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 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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hopital Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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