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

University of Modena and Reggio Emilia

Status and phase: Unknown; Phase 4

Conditions: Respiratory Tract Diseases; Immune System Diseases; Cardiovascular Diseases; Nervous System Diseases

Treatments: Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT01319643

OXYGEN-TIPO-1.0-30-09-2009

2009-016506-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 660 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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660 participants in 2 patient groups

Oxygenation, rigorous normal

Experimental group

Description:

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.

Treatment:

Drug: Oxygen

Oxygen, free conventional

No Intervention group

Description:

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.