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Clinical Trials in Ireland / NCT05492344
Recruiting Not applicable

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

NCT05492344 · tracked via the Priya Life Science Ireland tracker
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase
Not applicable
Started
2022-08-09
Last updated
2026-05-27

Condition(s) studied

ARDS, HumanLung UltrasoundMechanical Ventilation

Investigational drug(s) / intervention(s)

Personalized ventilationStandard care

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Chu-Brugmann Brussels Belgium Recruiting
Bispebjerg Hospital Copenhagen Denmark Recruiting
Nordsjaellands Hospital Hillerød Denmark Recruiting
Evaggelismos Hospital Athens Greece Recruiting
Galway University Hospitals Galway Ireland Recruiting
Ospedale Generale Regionale F. Miulli Acquaviva delle Fonti Bari Recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy Recruiting
Amsterdam UMC, location VUmc Amsterdam North Holland Recruiting
Amsterdam UMC, location AMC Amsterdam North Holland Recruiting
Centralny Szpital Kliniczny MSWiA Warsaw Poland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05492344 on ClinicalTrials.gov ↗ ← All trials in Ireland