Personalized Mechanical Ventilation Using Lung Ultrasound to Reduce Mortality in Adults with Moderate or Severe Acute Respiratory Distress Syndrome
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-05-27
538
Participants Needed
10
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating if personalized mechanical ventilation guided by lung ultrasound LUS can reduce mortality in adult patients with moderate or severe acute respiratory distress syndrome ARDS. ARDS is a serious condition causing low oxygen levels with a high death rate, and identifying lung types as focal or non-focal using LUS may allow tailored ventilation strategies. This multicenter randomized clinical trial aims to compare this personalized approach with standard mechanical ventilation practices.
Participants will receive a lung ultrasound exam within 12 hours of ARDS diagnosis to classify lung morphology. Patients will then be randomly assigned either to a group receiving personalized ventilation adjusting settings based on lung type or to a control group receiving standard care ventilation. Personalized ventilation includes specific settings for focal or non-focal ARDS, such as tidal volume, positive end-expiratory pressure PEEP, daily positioning, and repeated ultrasound assessments. The control group will receive ventilation based on established guidelines including standard tidal volume and oxygen settings.
Throughout the study, researchers will monitor all-cause mortality at 90 days as the primary outcome. Additional outcomes include mortality at 28 days, ventilator-free days, ICU and hospital length of stay, mortality, and complications like pneumonia or pneumothorax. The study includes safety and feasibility evaluations after the first 80 patients, with data collected from medical records and regular ultrasound exams. Participation involves standard ICU care procedures, and the burden or risks related to the study interventions are considered low.
CONDITIONS
Brief Title
Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome
Research Team
J
Jante S Sinnige, M.D.
M
Marry R Smit, Dr.
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Invasive ventilation at home due to neurological disease
Pregnancy
Moribund or facing end of life
Lack of informed consent
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 90 days from diagnosis of ARDS
Participants receive mechanical ventilation personalized by lung ultrasound assessment or standard care according to random assignment. Lung ultrasound exams are performed within 12 hours after ARDS diagnosis and repeated every 48 to 72 hours for those with focal ARDS to guide ventilator settings.
Initial ultrasound and ventilation settings plus ultrasound reassessments every 48 to 72 hours for some participants
Follow-up
Duration - Up to 90 days after inclusion
Participants are monitored for outcomes including mortality, ventilator-free days, ICU and hospital length of stay, and complications up to 90 days after inclusion.
Visits and assessments as part of hospital and ICU stay monitoring
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial.