Normal Oxygenation Versus Hyperoxia in the Intensive Care Unit (ICU) (OXYGEN-ICU)
Recruitment status was Recruiting
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.
Nervous System Diseases
Respiratory Tract Diseases
Immune System Diseases
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial|
- Mortality in ICU [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Rate of organ dysfunctions (respiratory, circulation, renal, liver) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||November 2011|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Experimental: 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.
The lowest inspiratory fraction of oxygen between 21 and 100% in as a short time as possible to maintain SpO2 between 94 and 98% or PaO2 between 70 and 100 mmHg.
No Intervention: Oxygen, free conventional
Patients admitted in intensive care units for 3 days. Administration of oxygen inspiratory fractions to maintain SpO2 over 97%, up to a PaO2 of 150 mmHg. Oxygen addition administer for transports or diagnostic manoeuvres. Conventional clinical criteria for airways control and ventilation technique.
|Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena||Recruiting|
|Modena, Italy, 41124|
|Contact: Massimo Girardis, PD 0594224934 ext 0039 firstname.lastname@example.org|
|Contact: Laura Rinaldi, MD 0594224896 ext 0039 email@example.com|
|Sub-Investigator: Stefano Busani, MD|
|Sub-Investigator: Laura Rinaldi, MD|
|Principal Investigator:||Massimo Girardis, PD||Università di Modena e Reggio Emilia|