Status:
RECRUITING
Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.
Lead Sponsor:
Centre Hospitalier Régional d'Orléans
Conditions:
Acute Respiratory Distress Syndrome
Prone Position
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Acute Respiratory Distress Syndrome (ARDS) is defined according to the Berlin definition (1) as diffuse lung damage occurring in patients with a predisposing risk factor. Positioning in the prone pos...
Detailed Description
Cross-over study, according to 4 preset sequences of 4 periods and randomly assigned. All patients will thus have the classic positioning technique (PP), as well as the technique under study (vertical...
Eligibility Criteria
Inclusion
- Major patient \> 18 years of age
- ARDS patients with PaO2/FiO2 ratio \< 150 at any time within 24 hours prior to the screening visit
- Hemodynamically stable patient with mean arterial pressure (MAP) \> 65 mmHg maintained without vasopressor or with norepinephrine at a dosage of less than 0.5 µg/kg/min.
- Patient having already undergone at least 1 but less than 5 PP sessions
- Patient under continuous intravenous sedation (IVSE) or not responding to simple order.
- Written consent of support person or family.
Exclusion
- Pregnant women (positive pregnancy test during screening)
- Breastfeeding women
- Protected Majors
- Body weight greater than 198 kg (bed load limit)
- Patient with one or two lower limbs amputated at the trans tibial or upper level
- Contraindication to standing (orthopedic fracture, neurological instability with the presence of an intracranial pressure sensor or an external ventricular shunt....)
- Deep venous thrombosis of the lower limbs with curative anticoagulation for less than 48 hours
- Hemodynamic instability (MAP \< 65 mm Hg) despite the use of norepinephrine at a dosage equal or greater than 0.5 µg/kg/min.
- Person under guardianship or trusteeship
- Non-beneficiary patient of a health insurance plan
- Moribund patient
Key Trial Info
Start Date :
October 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 14 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04472260
Start Date
October 15 2021
End Date
July 14 2026
Last Update
December 30 2025
Active Locations (1)
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1
CHR d'ORLEANS
Orléans, France