Personalized mechanical ventilation guided by lung ultrasound in patients with ARDS: a pilot phase of a randomized clinical trial.
Jante S Sinnige, Marry R Smit, Mohammad J Alam...
https://pubmed.ncbi.nlm.nih.gov/41423518Actively Recruiting
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
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
Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 10 locations
1
Chu-Brugmann
Brussels, Belgium
Actively Recruiting
2
Bispebjerg Hospital
Copenhagen, Denmark
Actively Recruiting
3
Nordsjaellands Hospital
Hillerød, Denmark
Actively Recruiting
4
Evaggelismos Hospital
Athens, Greece
Actively Recruiting
5
Galway University Hospitals
Galway, Ireland
Actively Recruiting
6
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, Bari, Italy
Actively Recruiting
7
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
Actively Recruiting
8
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands, 1081HV
Actively Recruiting
9
Amsterdam UMC, location AMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
10
Centralny Szpital Kliniczny MSWiA
Warsaw, Poland
Actively Recruiting
J
Jante S Sinnige, M.D.
M
Marry R Smit, Dr.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Jante S Sinnige, Marry R Smit, Mohammad J Alam...
https://pubmed.ncbi.nlm.nih.gov/41423518Jante S Sinnige, Marry R Smit, Aniruddha Ghose...
https://pubmed.ncbi.nlm.nih.gov/38715118