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

NCT04472260 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Régional d'Orléans

Phase

Not applicable

Started

2021-10-15

Last updated

2025-12-30

Condition(s) studied

Acute Respiratory Distress SyndromeProne Position

Investigational drug(s) / intervention(s)

Verticalization and Prone position

Verticalization and Prone position: 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Percentage of patients who were able to reach 55° of verticalization without serious adverse events (with a complete listing of all adverse events). — Month 1
To demonstrate the feasibility and safety in routine practice of the verticalization technique for patients with moderate to severe ARDS in the acute phase.

Trial sites (1)

Facility	City	Region	Status
CHR d'ORLEANS	Orléans	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04472260 on ClinicalTrials.gov ↗ ← All trials in France