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
Recruitment status was Recruiting
Sponsor:
University of Modena and Reggio Emilia
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
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ]
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01319643
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 |
| Study First Received: | August 30, 2010 |
| Last Updated: | March 21, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Modena and Reggio Emilia:
|
Oxygen Hyperoxia Intensive care unit |
Mortality Organ dysfunction Postoperative care |
Additional relevant MeSH terms:
|
Immune System Diseases Nervous System Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on March 03, 2015