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Assessing the Effectiveness of Low Tidal Volume and Low Driving Pressure in Mechanically Ventilated Severe Hypoxemic Patients: a Multicenter Emulated Target Trial
The present study set up to answer two questions: (a) "how low tidal volume must be to provide protective ventilatory settings able to minimize the risk of death due to Ventilator-Induced Lung Injury (VILI)?"; (b) "if protection from VILI is better achieved by targeting the driving pressure instead of the tidal volume, what is the optimal target for the driving pressure?". Solving these questions is pivotal for clinicians to personalized and precise mechanical ventilation practices to reduce the risk of VILI and avoid unnecessary risks associated to protective ventilatory settings. Two multicenter emulated target trials will be performed using data collected with the Electronic Health Record MargheritaTre, to investigate the effect of low tidal volumes (6.0 to 8.0 ml/kg PBW vs 8.0 to 10.0 ml/kg PBW) and low driving pressures (7.0-12.0 cmH2O vs 12.0-18.0 cmH2O), respectively. Data will be used to obtain the dose-response curve of lower VT and lower ∆P in mechanically ventilated patients with acute severe hypoxemia.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mario Negri Institute for Pharmacological Research IRCCS
Ranica, BG, Italy
Start Date
December 24, 2024
Primary Completion Date
August 1, 2025
Completion Date
December 31, 2025
Last Updated
December 27, 2024
4,300
ESTIMATED participants
low tidal volume
DEVICE
high tidal volume
DEVICE
low driving pressure
DEVICE
high driving pressure
DEVICE
Lead Sponsor
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Collaborators
NCT07414056
NCT06701669
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07246837