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Normal Oxygenation Versus Hyperoxia in the Intensive Care Unit (ICU) (OXYGEN-ICU)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Modena and Reggio Emilia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01319643
First received: August 30, 2010
Last updated: March 21, 2011
Last verified: August 2010
History of Changes

August 30, 2010
March 21, 2011
December 2009
November 2010   (final data collection date for primary outcome measure)
Mortality in ICU [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01319643 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Normal Oxygenation Versus Hyperoxia in the Intensive Care Unit (ICU)
Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Nervous System Diseases
  • Respiratory Tract Diseases
  • Cardiovascular Diseases
  • Immune System Diseases
Drug: Oxygen
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.
  • 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.
    Intervention: Drug: Oxygen
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
660
November 2011
November 2010   (final data collection date for primary outcome measure)

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:

  • minority
  • patient discharged from ICU and successively re-admitted
  • patient enrolled in other studies
  • expected survival shorter than 24 hours
Both
18 Years and older
No
Not Provided
Italy
 
NCT01319643
OXYGEN-TIPO-1.0-30-09-2009, 2009-016506-17
No
Massimo Girardis, Università di Modena e Reggio Emilia
University of Modena and Reggio Emilia
Not Provided
Principal Investigator: Massimo Girardis, PD Università di Modena e Reggio Emilia
University of Modena and Reggio Emilia
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP