Normal Oxygenation Versus Hyperoxia in the Intensive Care Unit (ICU) (OXYGEN-ICU)
|ClinicalTrials.gov Identifier: NCT01319643|
Recruitment Status : Unknown
Verified August 2010 by University of Modena and Reggio Emilia.
Recruitment status was: Recruiting
First Posted : March 22, 2011
Last Update Posted : March 22, 2011
|Condition or disease||Intervention/treatment||Phase|
|Nervous System Diseases Respiratory Tract Diseases Cardiovascular Diseases Immune System Diseases||Drug: Oxygen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||660 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||November 2011|
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.
- Mortality in ICU [ Time Frame: 30 days ]
- Rate of organ dysfunctions (respiratory, circulation, renal, liver) [ Time Frame: 30 days ]
- Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital. [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319643
|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|