Status:
ACTIVE_NOT_RECRUITING
Effectiveness of Low Volume and Low Pressure in Severe Hypoxemic Patients
Lead Sponsor:
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
Collaborating Sponsors:
Istituto Di Ricerche Farmacologiche Mario Negri
University of Bari Aldo Moro
Conditions:
Hypoxemia
Ards
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- all the following conditions present continuously for 24 hours commencing within 36 hours of ICU admission, while the patient is undergoing invasive mechanical ventilation in either flow or pressure- regulated assist/controlled modes:
- arterial oxygen tension (PaO2) to inspiratory oxygen fraction (FiO2) ratio P/F ≤ 300 mmHg
- hypoxemia developed within one week of a known clinical insult
- hypoxemia not fully explained by cardiac failure or fluid overload\*
Exclusion
- pregnancy
- expected duration of mechanical ventilation \< 48h
- severe or moderate COPD
- chronic liver disease
- acute brain injury
- patient admitted for palliative sedation
- tumor with metastases
- prior cardiac arrest
- New York Heart Association Class IV
- acute coronary syndrome
- patients transferred from other ICUs
- patients transferred to the ICU from the Emergency Department after a duration exceeding 24 hours in the Emergency Department
- patients on Pressure Support Ventilation and/or patients in whom end-inspiratory plateau pressure was not measured
Key Trial Info
Start Date :
December 24 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
4300 Patients enrolled
Trial Details
Trial ID
NCT06513299
Start Date
December 24 2024
End Date
December 31 2025
Last Update
December 27 2024
Active Locations (1)
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1
Mario Negri Institute for Pharmacological Research IRCCS
Ranica, BG, Italy, 24020