Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Respiratory Distress Syndrome
- Prone Position
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: In order to compare the effect of prone position (PP) and verticalization (V) on the PaO2/FiO2 ratio (secondary objective of the study), a randomized cross-over experimental design was chosen. Patients will be randomly assigned to one of the following 4 sequences. They will each include 4 treatment periods: Sequence 1: PP->PP->V->V, Sequence 2: PP->V->V->PP, Sequence 3: V->PP->PP->V Sequence 4: V->V->PP->PPMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 (verticalization). For simplicity, the investigators will use the term "verticalization" even if the final po...
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 (verticalization). For simplicity, the investigators will use the term "verticalization" even if the final positioning that is targeted is only a "pseudo-verticalization" to a 55° angle. The cross-over scheme with 4 sequences of 4 periods allows to get rid of the first order carry-over effect. Progressive verticalization protocol in 7 steps from the strict supine position to a 55° inclination of the raising bed, according to the clinical responses of the patient with ARDS, as follows: - Verticalization in the bed The verticalization maneuver will take place in 7 steps of 15 minutes maximum each: S1. The first one corresponds to the flat position (strict dorsal decubitus) S2. The second is the positioning of the patient at 25° of inclination. S3. The third is the 45° positioning S4. The fourth at 55°, which corresponds to the greatest inclination imposed to the patient. S5. The fifth corresponds to the 45° return S6. The sixth is the return to 25° S7. Finally, the investigators reposition the patient flat back. Examinations: Arterial Gazometry At the beginning, at the end and one hour after each positioning technique. Chest ultrasound Others All adverse events will be recorded in a clear and detailed manner.
Tracking Information
- NCT #
- NCT04472260
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Mai-ANh NAY, Dr CHR Orléans
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