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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016506-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygenation, rigorous normal | Experimental | 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. |
|
| Oxygen, free conventional | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality in ICU | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of organ dysfunctions (respiratory, circulation, renal, liver) | 30 days | |
| Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Girardis, PD | Università di Modena e Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena | Recruiting | Modena | Modena | 41124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27706466 | Derived | 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. |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012140 | Respiratory Tract Diseases |
| D002318 | Cardiovascular Diseases |
| D007154 | Immune System Diseases |
| D018496 | Hyperoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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