Comparing two techniques for positioning patients to prevent pressure sores in ICU
Evaluation Two Different Prone Position Techniques on the Occurrence of Pressure Sores in Patients With Invasive Mechanical Ventilation With Acute Respiratory Distress Syndrome in the Intensive Care Unit : a Multicenter, Prospective Randomized Controlled Trial.
This study is testing two different ways of positioning patients in the ICU to see which one better prevents pressure sores for those with severe breathing problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 334 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 1 site (Orléans) |
| Trial ID | NCT05894291 on ClinicalTrials.gov |
What this trial studies
This study compares two different prone position techniques used in the intensive care unit to assess their effectiveness in preventing pressure sores in patients with acute respiratory distress syndrome (ARDS). The prone position is known to improve oxygenation and reduce lung injury in ARDS patients, but it may also lead to pressure ulcers. By evaluating the swimmer prone position against the traditional prone position with arms alongside the body, the study aims to determine which method is more effective in minimizing the occurrence of pressure sores. The study involves intubated patients on mechanical ventilation who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are intubated patients with moderate to severe ARDS requiring prone positioning.
Not a fit: Patients with existing pressure ulcers or those who cannot be positioned in either technique will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient care by reducing the incidence of pressure sores in critically ill patients.
How similar studies have performed: Previous studies have shown that prone positioning can improve outcomes in ARDS patients, but the specific comparison of these two techniques is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Intubated patient on invasive mechanical ventilation with moderate to severe acute respiratory distress syndrome according to the BERLIN classification with a P/F ratio \< 150, requiring prone position. * Express consent of the patient or representative or in the absence of this, emergency inclusion procedure * Health insurance coverage Exclusion Criteria: * Patient with 2 (or more) Prone position sessions * Patient in whom one of the two positions could not be achieved: (Joint limitation; Neck size that would prevent head rotation; Orthopaedic spinal or segmental trauma; BMI greater than 45) * Presence of stage 2 or higher pressure ulcers on the anterior parts of the body at screening * Presence of extracorporeal membrane oxygenation (ECMO) * Patient already included in the study * Pregnant or breastfeeding woman * Patient under legal protection
Where this trial is running
Orléans
- UHT of Orléans — Orléans, France (Recruiting)
Study contacts
- Study coordinator: Guillaume FOSSAT
- Email: guillaume.fossat@chr-orleans.fr
- Phone: 0033238651318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.