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

ARDS, Human Mechanical Ventilation Lung Ultrasound

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

Inclusion Criteria3

Admitted to a participating ICU,
invasively ventilated and
fulfil the Berlin criteria for moderate or severe ARDS.

Exclusion Criteria14

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 are moribund or facing end of life and
no informed consent.

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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