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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by University of Modena and Reggio Emilia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01319643
First Posted: March 22, 2011
Last Update Posted: March 22, 2011
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.
Information provided by:
University of Modena and Reggio Emilia
  Purpose
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.

Condition Intervention Phase
Nervous System Diseases Respiratory Tract Diseases Cardiovascular Diseases Immune System Diseases Drug: Oxygen Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • Mortality in ICU [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 660
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)
Arms Assigned Interventions
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.
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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • minority
  • patient discharged from ICU and successively re-admitted
  • patient enrolled in other studies
  • expected survival shorter than 24 hours
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319643


Locations
Italy
Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena Recruiting
Modena, Italy, 41124
Contact: Massimo Girardis, PD    0594224934 ext 0039    girardis.massimo@unimore.it   
Contact: Laura Rinaldi, MD    0594224896 ext 0039    rinaldi.laura@unimore.it   
Sub-Investigator: Stefano Busani, MD         
Sub-Investigator: Laura Rinaldi, MD         
Sponsors and Collaborators
University of Modena and Reggio Emilia
Investigators
Principal Investigator: Massimo Girardis, PD Università di Modena e Reggio Emilia
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Massimo Girardis, Università di Modena e Reggio Emilia
ClinicalTrials.gov Identifier: NCT01319643     History of Changes
Other Study ID Numbers: OXYGEN-TIPO-1.0-30-09-2009
2009-016506-17 ( EudraCT Number )
First Submitted: August 30, 2010
First Posted: March 22, 2011
Last Update Posted: March 22, 2011
Last Verified: August 2010

Keywords provided by University of Modena and Reggio Emilia:
Oxygen
Hyperoxia
Intensive care unit
Mortality
Organ dysfunction
Postoperative care

Additional relevant MeSH terms:
Cardiovascular Diseases
Nervous System Diseases
Respiratory Tract Diseases
Immune System Diseases