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RECRUITING
NCT05492344
NA

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

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

538

Start Date

2022-08-09

Completion Date

2027-11-01

Last Updated

2025-12-08

Healthy Volunteers

No

Interventions

OTHER

Personalized 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

OTHER

Standard 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