RecruitingNot ApplicableNCT04472260

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

Sponsor

Centre Hospitalier Régional d'Orléans

Enrollment

32 participants

Start Date

Oct 15, 2021

Study Type

INTERVENTIONAL

Conditions

Prone Position Acute Respiratory Distress Syndrome

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This French ICU study investigates whether it is safe and feasible to vertically position (stand up) critically ill patients with Acute Respiratory Distress Syndrome (ARDS) who are on ventilators and have already undergone prone positioning (lying face-down). ARDS is a life-threatening lung condition. Early mobilization, including standing, is thought to aid lung recovery, reduce muscle wasting, and improve breathing. This study carefully tests whether this is safe even in mechanically ventilated patients. You may be eligible if... - You are 18 or older with ARDS and a PaO2/FiO2 ratio below 150 - Your blood pressure is stable (MAP above 65mmHg with low or no vasopressors) - You have already completed 1 but fewer than 5 prone positioning sessions - You are under continuous sedation or not responsive to commands - A family member or support person has given consent on your behalf You may NOT be eligible if... - You are pregnant - You weigh more than 198 kg - You have both lower limbs amputated above the ankle - You have a contraindication to standing (fractures, intracranial pressure monitoring) - Your blood pressure is critically unstable This study is conducted in ICU settings and decisions are made by treating physicians and family members on behalf of the critically ill patient.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREVerticalization 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.