Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Oxygen
- Conditions
- Nervous System Diseases
- Sponsor
- University of Modena and Reggio Emilia
- Enrollment
- 660
- Locations
- 1
- Primary Endpoint
- Mortality in ICU
- Last Updated
- 15 years ago
Overview
Brief Summary
Oxygen administration is a common practice in intensive care units, although concern is growing about oxygen toxicity. The aim of the study is to access whether a rigorous maintenance of a state of normal oxygenation in critically ill patients could obtain better outcomes, such as mortality, infections and organ failures, in comparison to conventional oxygen therapy practice.
Investigators
Eligibility Criteria
Inclusion Criteria
- •all patients admitted in a post-operative and medical intensive care unit with expected admission of at least three days. Informed consensus as soon as possible
Exclusion Criteria
- •patient discharged from ICU and successively re-admitted
- •patient enrolled in other studies
- •expected survival shorter than 24 hours
Arms & Interventions
Oxygenation, rigorous normal
Patients admitted in intensive care unit for 3 days. Administration of the lowest inspiratory fraction dose of oxygen to maintain oxygen peripheral saturation (SpO2) between 94 and 98% or an arterial partial pressure of oxygen (PaO2) between 70 and 100 mmHg. No oxygen addition administer for transports or diagnostic manoeuvres. Conventional clinical criteria for airways control and ventilation technique.
Intervention: Oxygen
Outcomes
Primary Outcomes
Mortality in ICU
Time Frame: 30 days
Secondary Outcomes
- Rate of organ dysfunctions (respiratory, circulation, renal, liver)(30 days)
- Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital.(30 days)