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

Phase 4UnknownNCT01319643

University of Modena and Reggio Emilia660 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

660

Conditions

Nervous System Diseases Respiratory Tract Diseases Cardiovascular Diseases Immune System Diseases

Interventions

OxygenDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Modena, Italy

RECRUITING

Outcomes

Primary Outcomes

Mortality in ICU

Time frame: 30 days

Secondary Outcomes

Rate of organ dysfunctions (respiratory, circulation, renal, liver)

Time frame: 30 days

Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital.

Time frame: 30 days

Data from ClinicalTrials.gov

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