Nervous System DiseasesPhase 4OXYGEN-ICUNCT01319643
Normal Oxygenation Versus Hyperoxia in the Intensive Care Unit (ICU)
A Phase 4 study testing Oxygen in people with Nervous System Diseases and Respiratory Tract Diseases, run by University of Modena and Reggio Emilia at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nervous System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2009to Nov 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- minority
- patient discharged from ICU and successively re-admitted
- patient enrolled in other studies
- expected survival shorter than 24 hours
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Modena, 41124
Massimo Girardis, PD, 0594224934 ext. 0039, girardis.massimo@unimore.it
Laura Rinaldi, MD, 0594224896 ext. 0039, rinaldi.laura@unimore.it
About this study
Official title: Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial
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.
- Conditions
- Nervous System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases, Immune System Diseases
- Being tested
- Oxygen
- Keywords
- Oxygen, Hyperoxia, Intensive care unit, Mortality, Organ dysfunction, Postoperative care
- Medical subject headings
- Nervous System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases, Immune System Diseases, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality in ICU
Measured: 30 days
Secondary outcomes (2)
Rate of organ dysfunctions (respiratory, circulation, renal, liver)
Measured: 30 days
Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startDec 2009
- Primary completionNov 2010 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Investigators
- Massimo Girardis, PD, Principal investigator, Università di Modena e Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319643
- Sponsor's protocol ID
- OXYGEN-TIPO-1.0-30-09-2009
- Other IDs
- 2009-016506-17, 2009
- Acronym
- OXYGEN-ICU
- Status last verified
- Aug 2010
- First submitted
- 30 Aug 2010
- Last updated
- 22 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27706466
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Oxygenation Maintenance in Intensive Care Unit: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01319643
- Acronym / sponsor ID
- OXYGEN-ICU / OXYGEN-TIPO-1.0-30-09-2009
- Conditions
- Nervous System Diseases, Respiratory Tract Diseases, Cardiovascular Diseases, Immune System Diseases
- Keywords
- Oxygen, Hyperoxia, Intensive care unit, Mortality, Organ dysfunction, Postoperative care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygenation, rigorous normal | Experimental | Drug: OxygenPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- minority
- patient discharged from ICU and successively re-admitted
- patient enrolled in other studies
- expected survival shorter than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenThe 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. | Drug | Oxygenation, rigorous normal |
Primary outcome
Mortality in ICU
Time frame: 30 days
2 secondary outcomes
Rate of organ dysfunctions (respiratory, circulation, renal, liver)
Time frame: 30 days
Rate of nosocomial blood and respiratory infections in intensive care unit and surgery site infections in hospital.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2011.
- Derived from this study: PubMed 27706466Girardis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terapia Intensiva Post-operatoria. Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Italy
Massimo Girardis, PD principal investigator
Università di Modena e Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxygen in people with Nervous System Diseases and Respiratory Tract Diseases, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality in ICU (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01319643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2011; AzTrials last refreshed its copy on 1 Nov 2026.