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

Study Overview
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Brief Summary
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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.

Official Title
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Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial

Conditions
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Nervous System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases, Immune System Diseases

Intervention / Treatment
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* Drug: Oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygenation, rigorous normal<br>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<br>* 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.<br>|
| No Intervention: Oxygen, free conventional<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality in ICU |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperoxia, Intensive care unit, Mortality, Organ dysfunction, Postoperative care, Oxygen