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

Primary Purpose

Nervous System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Oxygen
Sponsored by
University of Modena and Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nervous System Diseases focused on measuring Oxygen, Hyperoxia, Intensive care unit, Mortality, Organ dysfunction, Postoperative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di ModenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Oxygenation, rigorous normal

Oxygen, free conventional

Arm 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.

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.

Outcomes

Primary Outcome Measures

Mortality in ICU

Secondary Outcome Measures

Rate of organ dysfunctions (respiratory, circulation, renal, liver)
Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital.

Full Information

First Posted
August 30, 2010
Last Updated
March 21, 2011
Sponsor
University of Modena and Reggio Emilia
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1. Study Identification

Unique Protocol Identification Number
NCT01319643
Brief Title
Normal Oxygenation Versus Hyperoxia in the Intensive Care Unit (ICU)
Acronym
OXYGEN-ICU
Official Title
Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2010 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Modena and Reggio Emilia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nervous System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases, Immune System Diseases
Keywords
Oxygen, Hyperoxia, Intensive care unit, Mortality, Organ dysfunction, Postoperative care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oxygenation, rigorous normal
Arm Type
Experimental
Arm 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.
Arm Title
Oxygen, free conventional
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality in ICU
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of organ dysfunctions (respiratory, circulation, renal, liver)
Time Frame
30 days
Title
Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Girardis, PD
Organizational Affiliation
Università di Modena e Reggio Emilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Girardis, PD
Phone
0594224934
Ext
0039
Email
girardis.massimo@unimore.it
First Name & Middle Initial & Last Name & Degree
Laura Rinaldi, MD
Phone
0594224896
Ext
0039
Email
rinaldi.laura@unimore.it
First Name & Middle Initial & Last Name & Degree
Stefano Busani, MD
First Name & Middle Initial & Last Name & Degree
Laura Rinaldi, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
27706466
Citation
Girardis M, Busani S, Damiani E, Donati A, Rinaldi L, Marudi A, Morelli A, Antonelli M, Singer M. Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1583-1589. doi: 10.1001/jama.2016.11993.
Results Reference
derived

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

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