NCT01319643

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
660

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

March 22, 2011

Status Verified

August 1, 2010

Enrollment Period

11 months

First QC Date

August 30, 2010

Last Update Submit

March 21, 2011

Conditions

Nervous System DiseasesRespiratory Tract DiseasesCardiovascular DiseasesImmune System Diseases

Keywords

OxygenHyperoxiaIntensive care unitMortalityOrgan dysfunctionPostoperative care

Outcome Measures

Primary Outcomes (1)

  • Mortality in ICU

    30 days

Secondary Outcomes (2)

  • 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

Study Arms (2)

Oxygenation, rigorous normal

EXPERIMENTAL

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

Oxygen, free conventional

NO INTERVENTION

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.

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.

Oxygenation, rigorous normal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • minority
  • patient discharged from ICU and successively re-admitted
  • patient enrolled in other studies
  • expected survival shorter than 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Modena, Modena, 41124, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27706466DERIVED

MeSH Terms

Conditions

Nervous System DiseasesRespiratory Tract DiseasesCardiovascular DiseasesImmune System DiseasesHyperoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Massimo Girardis, PD

    Università di Modena e Reggio Emilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2010

First Posted

March 22, 2011

Study Start

December 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2011

Last Updated

March 22, 2011

Record last verified: 2010-08

Locations

IT(1)