RecruitingNot ApplicableNCT05492344

Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome


Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

538 participants

Start Date

Aug 9, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish 'focal' from 'non-focal' lung morphology. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition where the lungs fill with fluid, making breathing very difficult. Patients need mechanical ventilation, but the right settings are not always clear. This ICU study uses lung ultrasound to personalize ventilator settings for each patient, with the goal of reducing lung injury from the ventilator itself. You may be eligible if: • You are 18 years old or older • You are admitted to an ICU and on invasive mechanical ventilation • You meet the Berlin criteria for moderate or severe ARDS You may NOT be eligible if: • Ultrasound of your lungs is not technically possible (e.g., subcutaneous emphysema, morbid obesity, or wounds) • You have been on a ventilator for more than 7 consecutive days in the past 30 days • You have had ARDS in the past month • Your BMI is above 40 • You have intracranial hypertension or a bronchopleural fistula • You are on ECMO • You have severe pulmonary fibrosis or end-stage lung disease • You were previously enrolled in the PEGASUS study Talk to your doctor to see if this trial is right for you.

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

OTHERPersonalized ventilation

Patients who are randomized for personalized ventilation with FOCAL ARDS will receive the following ventilator settings: * Positive end-expiratory pressure (PEEP) ≤ 9 cm water (H2O) * Tidal volume: 6 to 8 mL/kg predicted body weight (PBW) * Daily prone positioning LUS will be repeated every 48-72 hours in supine position for the focal ARDS patients to assess whether they have developed non-focal ARDS during admission. In that case, patients will from then on be treated according non-focal personalized treatment protocol. Patients who are randomized for personalized ventilation with Non-FOCAL ARDS will receive the following ventilator settings: * PEEP ≥ 15 cm H2O * Tidal volume: 4 to 6 mL/kg PBW * Daily recruitment maneuver

OTHERStandard care

Patient who are randomized in the control group will receive standard care * Tidal volume: 6 mL/kg PBW * PEEP and FiO2 according to the low PEEP and high fraction of inspired oxygen (FiO2) table of the AlVEOLI study * Prone positioning if the Partial Pressure of Oxygen (PaO2) /FiO2 ratio is \< 150 mmHg


Locations(10)

Chu-Brugmann

Brussels, Belgium

Bispebjerg Hospital

Copenhagen, Denmark

Nordsjaellands Hospital

Hillerød, Denmark

Evaggelismos Hospital

Athens, Greece

Galway University Hospitals

Galway, Ireland

Ospedale Generale Regionale F. Miulli

Acquaviva delle Fonti, Bari, Italy

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Italy

Amsterdam UMC, location VUmc

Amsterdam, North Holland, Netherlands

Amsterdam UMC, location AMC

Amsterdam, North Holland, Netherlands

Centralny Szpital Kliniczny MSWiA

Warsaw, Poland

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NCT05492344


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