Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04472260

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

Led by Centre Hospitalier Régional d'Orléans · Updated on 2025-12-30

32

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years
  • Diagnosed with ARDS and PaO2/FiO2 ratio less than 150 within 24 hours before screening
  • Hemodynamically stable with mean arterial pressure above 65 mmHg without or with low-dose norepinephrine (<0.5 µg/kg/min)
  • Have undergone at least 1 but fewer than 5 prone position sessions
  • Under continuous intravenous sedation or unresponsive to simple commands
  • Written consent from a support person or family member
Not Eligible

You will not qualify if you...

  • Pregnant women or breastfeeding women
  • Protected adults under guardianship or trusteeship
  • Body weight over 198 kg (bed limit)
  • Amputation of one or both lower limbs at or above the transtibial level
  • Contraindications to standing such as fractures or neurological instability with intracranial pressure sensor or ventricular shunt
  • Deep vein thrombosis in lower limbs treated with anticoagulants for less than 48 hours
  • Hemodynamic instability with mean arterial pressure below 65 mmHg despite norepinephrine at doses ≥0.5 µg/kg/min
  • Patients without health insurance coverage
  • Moribund patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHR d'ORLEANS

Orléans, France

Actively Recruiting

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Research Team

A

Aurélie DESPUJOLS

CONTACT

E

Elodie POUGOUE TOUKO

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

4

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