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

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) • ClinicalTrials.gov ID: NCT05492344

Registry updated: 2026-10-15

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Description

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.

Interventions

Personalized ventilation (Other)
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
Standard care (Other)
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

Eligibility criteria

Inclusion Criteria: * Admitted to a participating ICU, * invasively ventilated and * fulfil the Berlin criteria for moderate or severe ARDS. Exclusion Criteria: * Age under 18, * participation in other interventional studies with conflicting endpoints, * conditions in which LUS is not feasible or possible (e.g. subcutaneous emphysema, morbid obesity or wounds), * mechanical ventilation for longer than 7 consecutive days in the past 30 days, * history of ARDS in the previous month, * body-mass index higher than 40 kg/m², * intracranial hypertension, * broncho-pleural fistula, * chronic respiratory diseases requiring long-term oxygen therapy or respiratory support, * pulmonary fibrosis with a vital capacity \< 50% (severe or very severe), * previously randomized in the PEGASUS study * ECMO * patients who receive invasive ventilation in home setting due to a neurological disease * pregnant patients * patients who are moribund or facing end of life and * no informed consent.

Conditions

ARDS, Human Lung Ultrasound Mechanical Ventilation

Locations

Chu-Brugmann — Brussels, Belgium
West China Hospital — Chengdu, China
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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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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