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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Modena and Reggio Emilia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01319643
First received: August 30, 2010
Last updated: March 21, 2011
Last verified: August 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Nervous System Diseases
Respiratory Tract Diseases
Cardiovascular Diseases
Immune System Diseases
 Drug: Oxygen
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • Mortality in ICU [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of organ dysfunctions (respiratory, circulation, renal, liver) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 660
Study Start Date: December 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 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.
No Intervention: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319643

Locations
Italy
Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena Recruiting
Modena, Italy, 41124
Contact: Massimo Girardis, PD     0594224934 ext 0039     girardis.massimo@unimore.it    
Contact: Laura Rinaldi, MD     0594224896 ext 0039     rinaldi.laura@unimore.it    
Sub-Investigator: Stefano Busani, MD            
Sub-Investigator: Laura Rinaldi, MD            
Sponsors and Collaborators
University of Modena and Reggio Emilia
Investigators
Principal Investigator: Massimo Girardis, PD Università di Modena e Reggio Emilia
  More Information

No publications provided

Responsible Party: Massimo Girardis, Università di Modena e Reggio Emilia
ClinicalTrials.gov Identifier: NCT01319643     History of Changes
Other Study ID Numbers: OXYGEN-TIPO-1.0-30-09-2009, 2009-016506-17
Study First Received: August 30, 2010
Last Updated: March 21, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Modena and Reggio Emilia:
Oxygen
Hyperoxia
Intensive care unit
 Mortality
Organ dysfunction
Postoperative care

Additional relevant MeSH terms:
Cardiovascular Diseases
Immune System Diseases
Nervous System Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013