Normal Oxygenation Versus Hyperoxia in the Intensive Care Unit (ICU) (OXYGEN-ICU)
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| ClinicalTrials.gov Identifier: NCT01319643 |
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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
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Sponsor:
University of Modena and Reggio Emilia
Information provided by:
University of Modena and Reggio Emilia
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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.
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Oxygen Therapy
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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 |
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 Posted: | March 22, 2011 Key Record Dates |
| Last Update Posted: | March 22, 2011 |
| Last Verified: | August 2010 |
Keywords provided by University of Modena and Reggio Emilia:
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Oxygen Hyperoxia Intensive care unit |
Mortality Organ dysfunction Postoperative care |
Additional relevant MeSH terms:
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Cardiovascular Diseases Nervous System Diseases Respiratory Tract Diseases Immune System Diseases |