Early Verticalization of the Patient With Acute Respiratory Distress Syndrome: Assessment of Feasibility and Safety.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 position (PP) has been shown to decrease mortality in patients with moderate to severe ARDS. However, this technique is not without deleterious effects such as ventilator-associated pneumonia, endotracheal tube obstruction, development of pressure ulcers, and increased workload for the caregivers. There are other positioning techniques such as the upright position, which simulates a relative verticality, which allows to increase the effects of the prone position and even in some patients to improve oxygenation without the PP in the acute phase of ARDS. However, given the revolution caused by the use of PP in ARDS patients, verticalization have not been studied in more details. Today, there is a bed on the market that allows patients to be truly upright without having to transfer them to a tilt table. The investigators believe that raising ARDS patients in the acute phase is safe and feasible in routine practice. In this research protocol comparing PP and verticalization in a crossover trial design in acute ARDS patients, the investigators want to show that this technique can be safe and feasible, with the same effects on oxygenation as PP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHR d'ORLEANS
RECRUITING
Orléans
Contact Information
Primary
Aurélie DESPUJOLS
aurelie.despujols@chr-orleans.fr
+33238744071
Backup
Elodie POUGOUE TOUKO
elodie.pougoue@chro-orleans.fr
+33238744086
Time Frame
Start Date: 2021-10-15
Estimated Completion Date: 2026-07-14
Participants
Target number of participants: 32
Treatments
Other: Sequence 1: PP->PP->V->V
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.
Other: Sequence 2: PP->V->V->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.
Other: Sequence 3: V->PP->PP->V
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.
Other: 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.
Sponsors
Leads: Centre Hospitalier Régional d'Orléans

This content was sourced from clinicaltrials.gov

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