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:

MedlinePlus related topics: Oxygen Therapy

U.S. FDA Resources

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.

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

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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):

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.


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

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