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Conservative vs Conventional Oxygen in ICU
NCT04198077Phase 4
Key facts
- Status
- Unknown
- Start
- Dec 2019
- Primary completion
- Dec 2022
- Countries
- 1
- Sponsor
- University of Modena and Reggio Emilia
- Modality
- Inhalation Devices
- Drugs
- oxygen
- Conditions
- respiratory failurecritical illness
01
Overview
Phase 4, randomised, open-label trial of oxygen in respiratory failure and critical illness (2 arms), sponsored by University of Modena and Reggio Emilia. Primary endpoint: Mortality at ICU Discharge. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Conservative Oxygen
Target SpO2 94-98%, PaO2 60-100 mmHg
Conventional Oxygen
Target SpO2 >= 98%, PaO2 up to 150 mmHg
03
Who it enrols
Adult critically ill patients requiring mechanical ventilation with an expected ICU stay > 72 hours, excluding those with severe ARDS, COPD exacerbation, or specific indications for hyperoxia.
04
Endpoints
Primary
Mortality at ICU Discharge
Secondary
90-day Mortality
Occurrence of New Organ Dysfunction
Occurrence of Nosocomial Infections
Ventilation-free Hours
Vasopressor-free Hours
Intensive Care Unit Free Days
Cognitive Dysfunction
ICU Acquired Weakness
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