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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-11-30

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.

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Detailed Description

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Conditions

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Nervous System Diseases Respiratory Tract Diseases Cardiovascular Diseases Immune System Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Oxygen

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

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