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

Phase 4

• Conditions: Nervous System Diseases; Respiratory Tract Diseases; Cardiovascular Diseases; Immune System Diseases
• Interventions: Drug: Oxygen

• Registration Number: NCT01319643
• Lead Sponsor: University of Modena and Reggio Emilia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Status Verified: 2010-08
• Study First Submitted: 2010-08-30
• Primary Completion: 2010-11
• Study First Submitted QC: 2011-03-21
• Last Update Submitted: 2011-03-21
• Study First Posted: 2011-03-22
• Last Update Posted: 2011-03-22
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 660

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygenation, rigorous normal	Oxygen	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.

Primary Outcome Measures

Name	Time	Method
Mortality in ICU	30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena; 🇮🇹 Modena, Italy