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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
University of Modena and Reggio Emilia

Tracking Information
First Submitted Date  ICMJE August 30, 2010
First Posted Date  ICMJE March 22, 2011
Last Update Posted Date March 22, 2011
Study Start Date  ICMJE December 2009
Estimated Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
Mortality in ICU [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Normal Oxygenation Versus Hyperoxia in the Intensive Care Unit (ICU)
Official Title  ICMJE Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Nervous System Diseases
  • Respiratory Tract Diseases
  • Cardiovascular Diseases
  • Immune System Diseases
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
Publications * Girardis M, Busani S, Damiani E, Donati A, Rinaldi L, Marudi A, Morelli A, Antonelli M, Singer M. Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1583-1589. doi: 10.1001/jama.2016.11993.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 21, 2011)
660
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2011
Estimated Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01319643
Other Study ID Numbers  ICMJE OXYGEN-TIPO-1.0-30-09-2009
2009-016506-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Massimo Girardis, Università di Modena e Reggio Emilia
Study Sponsor  ICMJE University of Modena and Reggio Emilia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Massimo Girardis, PD Università di Modena e Reggio Emilia
PRS Account University of Modena and Reggio Emilia
Verification Date August 2010

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