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

Cardiovascular Diseases Clinical Trial

— OXYGEN-ICU  

Official title:

Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01319643
• Other study ID #: OXYGEN-TIPO-1.0-30-09-2009
• Secondary ID: 2009-016506-17
• Status: Recruiting
• Phase: Phase 4
• First received: August 30, 2010
• Last updated: March 21, 2011
• Start date: December 2009
• Est. completion date: November 2011

Study information

• Verified date: August 2010
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: November 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Immune System Diseases
• Nervous System Diseases
• Respiratory Tract Diseases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Italy	Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality in ICU		30 days	Yes
Secondary	Rate of organ dysfunctions (respiratory, circulation, renal, liver)		30 days	Yes
Secondary	Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital.		30 days	Yes