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New nursing method aims to prevent bedsores in Face-Down ICU patients

NCT ID NCT03125421

Disease control Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study tested a special nursing strategy to prevent pressure sores in patients with severe lung problems who need to lie face down (prone position). The trial included 160 adults in intensive care who were on breathing machines. The strategy involved protecting the eyes, tilting the body, and moving the head regularly. The goal was to see if this approach reduced the number of new pressure sores compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nursing strategy (specific preventive methods for pressure sores)
What this could lead to
If successful, this nursing strategy could reduce the number of pressure sores in critically ill patients who need to lie face down, improving comfort and recovery.
What could go wrong
This is a completed trial, but its findings may not apply to all ICU settings or patient groups. The strategy involves multiple components, so it's unclear which part is most effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

160 people

The number who actually took part.

Started

Apr 2018

Finished

Jan 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome decubitus ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pressure sores

Contacts and locations

Locations

  • Hospices Civils de Lyon - Hopital Croix Rousse

    Lyon, 69004, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.