PSA: Prevention of Pressure Sores in the Prone Position in ARDS Patients

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT03125421

Collaborator

(none)

160

Enrollment

Location

Arms

32.9

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Sores	Procedure: standard preventive methods of pressure sores Procedure: experimental multifaceted preventive methods of pressure sores	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 :

Apr 16, 2018

Actual Primary Completion Date :

Jan 11, 2021

Actual Study Completion Date :

Jan 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: control period 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.

Arm

Intervention/Treatment

Other: control period

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospices Civils de Lyon - Hopital Croix Rousse	Lyon		France	69004

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Lucile Gay, Hospices Civils de Lyon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT03125421

Other Study ID Numbers:

69HCL17_0039

First Posted:

Apr 24, 2017

Last Update Posted:

May 4, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pressure Ulcer

Study Results

No Results Posted as of May 4, 2021