Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety. (STAND_ARDS1)
Acute Respiratory Distress Syndrome, Prone Position
About this trial
This is an interventional other trial for Acute Respiratory Distress Syndrome focused on measuring Acute respiratory distress syndrome, Verticalization, Intensive Care Unit, Prone position
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- CHR d'ORLEANSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
Sequence 1: PP->PP->V->V
Sequence 2: PP->V->V->PP
Sequence 3: V->PP->PP->V
Saquence 4: V->V->PP->PP
The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS. The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.
The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS. The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.
The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS. The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.
The randomly selected study sequence (Arm1, Arm2, Arm3 or Arm4) will begin after the supine roll-over at the end of the first PP session (out-of-study sequence). This allows all patients to initially have the positioning technique that has been proven beneficial in ARDS. The chronology of the treatment periods in each of the 4 arms allocated by randomization will be as follows: Each PP must be started within 4 to 8 hours after the end of the previous PP or after the end of the verticalization that just preceded it. Each verticalization must be performed within 4 to 8 hours after the end of the previous PP or the previous verticalization. Each PP period will last between 12 and 20 hours.