Intensive Care UnitsORI2NCT02878460
ORI2 : ORI for hyperOxia Reduction in ICU
A study testing monitoring with ORI + SpO2 and monitoring with SpO2 in people with Intensive Care Units, run by University Hospital, Angers at 1 site in France.
Trial summary
Recently, hyperoxia has been recognized as being potentially deleterious for critically ill patients, with increased duration of mechanical ventilation and even with increased mortality rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Units
- What is being tested?
- monitoring with ORI + SpO2 and monitoring with SpO2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2017to 22 May 2018
- Phase
- Interventional
- 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
- Patient hospitalized in ICU of Angers hospital
- Patient intubated and mechanically ventilated for an expected period of at least 2 days
- Inclusion is to achieve within 6 hours after admission (for admitted patients intubated ) or at the time of intubation (for non- intubated patients on admission )
Who cannot join
- Pregnant Woman
Trial locations and contacts
1 site in 1 country.
About this study
Recently, hyperoxia has been recognized as being potentially deleterious for critically ill patients, with increased duration of mechanical ventilation and even with increased mortality rates. This could be related to pulmonary lesions (including notably atelectasis) but also to increased tissue damage and organ dysfunctions, secondary to increased/induced oxidative stress. At last higher FiO2 led to "over-consumption" of oxygen and therefore to additional costs. Usually, FiO2 and oxygen flows are modified according to the monitoring of SpO2. But, it has also been recognized that modifying FiO2 (and oxygen flows) according to SpO2 monitoring is not routinely (or easily) done. Indeed, nurses (and doctors) are reluctant to reduce oxygen flows when everything appear under control.
The ORI (Oxygen Reserve Index) is an index measured using non-invasive SpO2 sensors (Rainbow sensors- MASIMO) that evaluates non-invasively PaO2 (partial pressure of oxygen). An ORI ≤0 indicates that PaO2 is less than 100 mmHg. When ORI increases (i.e. ORI≥0.01) PaO2 is higher than 100 mmHg. This index increases up to 1. ORI between 0.01 and 1 indicates that PaO2 is probably between 100 and 200 mmHg. Thus, monitoring critically ill patients using the ORI, may help identifying when PaO2 is high and when FiO2 (or oxygen flows in non-intubated patients) may be reduced. This could help reducing the time with hyperoxia (i.e. PaO2 ≥100 mmHg or ≥80 mmHg).
The purpose of this feasibility study is to evaluate if the use of ORI can help to decrease length of moderate hyperoxia (PaO2>100mmHg) in critically ill patients, in comparison with monitoring the SpO2 only.
- Conditions
- Intensive Care Units
- Being tested
- monitoring with ORI + SpO2, monitoring with SpO2
- Keywords
- HYPEROXIA, MECHANICAL VENTILATION, OXYGEN RESERVE INDEX
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoring with ORI + SpO2Other
Also called ORI group
If ORI is equal to 0.00, the FiO2 (or oxygen flow) is not changed. if ORI is ≥ 0.01, Nurses must decrease the FiO2 (or oxygen flow) by 10%, until ORI is =0.
if SpO2 is < lower individualized limit, FiO2 (or oxygen flow) is increased by 10%, if it happens twice, doctors are called.
monitoring with SpO2Other
Also called Control group
If SpO2 is below the upper individualized limit, the FiO2 (or oxygen flow) is not changed.
If SpO2 is equal or above this limit, Nurses must reduce the FiO2 (or oxygen flow) by 10% every 10 minutes until SpO2 is ≤ upper individualized limit, with FiO2≥25 %.
if SpO2 is < lower individualized limit, FiO2 (or oxygen flow) is increased by 10%, if it happens twice, doctors are called.
| Study group | Role | What they receive |
|---|---|---|
| monitoring with ORI + SpO2 | Experimental | Patients receive the regular monitoring with SpO2, but in this group, the ORI parameters is shown on the scope.
Lower and upper SpO2 limits are prescribed for each patient. Receives: Other: monitoring with ORI + SpO2 |
| monitoring with SpO2 | Other | Patients receive the regular monitoring; the ORI parameters is not shown (but it is recorded each time a blood gas is drown).
Lower and upper SpO2 limits are prescribed for each patient. Receives: Other: monitoring with SpO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of days with moderate hyperoxia
The primary endpoint is the percentage of days with moderate hyperoxia. Moderate hyperoxia is defined by a PaO2> 100 mmHg - measured on blood gases obtained in usual practicePaO2 will be followed by the inclusion until the end of mechanical ventilation or D28 or ICU discharge. The percentage of days with moderate hyperoxia is (number of days of moderate hyperoxia / number of days of oxygen therapy) x100. The follow up will occurs from inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Measured: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Secondary outcomes (11)
Minimum and maximum daily FiO2
The secondary endpoints are the minimum and maximum daily FiO2, obtained by respirator in each group. FiO2 will be followed by the inclusion until the end of oxygenotherapy or D28.
Measured: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Minimum and maximum daily PaO2
The secondary endpoints are the minimum and maximum daily PaO2, (measured by blood gases obtained in usual practice ) . PaO2 will be followed by the inclusion until the end of oxygenotherapy or D28.
Measured: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Length of mechanical ventilation
The secondary endpoint is the length of mechanical ventilation, (unit: day number)
Measured: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Number of day with PaO2 equal or above to 80 mmHg
The secondary endpoint is the number of the day where patient is mechanically ventilated and has a PaO2 equal or above to 100 mmHg and 80 mmHg . PaO2 is measured by blood gases obtained in usual practice . this outcome will be followed by the inclusion until the end of mechanical ventilation or D28.
Measured: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Number of hypoxemia episode
The secondary endpoint is the number (in day) of hypoxemia (defined by PaO2<60 mmHg - measured by blood gases obtained in usual practice). PaO2 will be followed by the inclusion until the end of oxygenotherapy or D28.
Measured: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Number of day without mechanical ventilation at D28
The secondary endpoint is the number of day without mechanical ventilation at D28. It will be followed by the inclusion until D28.
Measured: inclusion to D28
Number of atelectasis episodes requiring specific medical care (that means fibro-aspiration or posture of patient)
The secondary endpoint is the number of atelectasis episodes requiring specific medical care. It will be followed by the inclusion until the end of mechanical ventilation or D28.
Measured: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Average daily PaO2
The primary endpoint is the average daily PaO 2 in each group (measured by blood gases obtained in usual practice ) . PaO2 will be followed by the inclusion until the end of oxygenotherapy or D28.
Measured: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Number of moderate hypoxemia hours
this outcomes follows the formula: Moderate hypoxia (in hours) = a + b. With a = the sum of the durations (in hours) between two GDS having a PaO2> 100mmHg and b = the sum of the half times (in hours) between a GDS having a PaO2> 100mmHg and a GDS having a PaO2 ≤ 100mmHg
Measured: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Maximum ORI values during pre-oxygenation before a endotracheal aspiration
The secondary endpoint is the maximum ORI values during pre-oxygenation before a endotracheal aspiration
Measured: At each pre-oxugenation before a endotracheal aspiration occurs from inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Minimum SpO2 within 15 minutes following a endotracheal aspiration
The primary endpoint is the minimum SpO2 within 15 minutes following a endotracheal aspiration, with or without recruitment maneuver.
Measured: At each endotracheal aspiration occurs from inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start27 Apr 2017
- Primary completion22 May 2018
- Study completion22 May 2018
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 Intensive Care UnitsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878460
- Sponsor's protocol ID
- CHU-P2016-04
- Other IDs
- 2016-A01026-45
- Acronym
- ORI2
- Status last verified
- Nov 2020
- First submitted
- 22 Aug 2016
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lasocki S, Brochant A, Leger M, Gaillard T, Lemarie P, Gergaud S, Dupre P. ORI monitoring allows a reduction of time with hyperoxia in critically ill patients: the randomized control ORI2 study. Intensive Care Med. 2019 Nov;45(11):1661-1662. doi: 10.1007/s00134-019-05732-9. Epub 2019 Aug 13. No abstract available.
PubMed 31410497
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORI2 : ORI for hyperOxia Reduction in ICU
- ClinicalTrials.gov ID
- NCT02878460
- Acronym / sponsor ID
- ORI2 / CHU-P2016-04
- Conditions
- Intensive Care Units
- Keywords
- HYPEROXIA, MECHANICAL VENTILATION, OXYGEN RESERVE INDEX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 22 May 2018 (actual)
- Study completion
- 22 May 2018 (actual)
- First posted
- 25 Aug 2016 (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.
Recently, hyperoxia has been recognized as being potentially deleterious for critically ill patients, with increased duration of mechanical ventilation and even with increased mortality rates. This could be related to pulmonary lesions (including notably atelectasis) but also to increased tissue damage and organ dysfunctions, secondary to increased/induced oxidative stress. At last higher FiO2 led to "over-consumption" of oxygen and therefore to additional costs. Usually, FiO2 and oxygen flows are modified according to the monitoring of SpO2. But, it has also been recognized that modifying FiO2 (and oxygen flows) according to SpO2 monitoring is not routinely (or easily) done. Indeed, nurses (and doctors) are reluctant to reduce oxygen flows when everything appear under control.
The ORI (Oxygen Reserve Index) is an index measured using non-invasive SpO2 sensors (Rainbow sensors- MASIMO) that evaluates non-invasively PaO2 (partial pressure of oxygen). An ORI ≤0 indicates that PaO2 is less than 100 mmHg. When ORI increases (i.e. ORI≥0.01) PaO2 is higher than 100 mmHg. This index increases up to 1. ORI between 0.01 and 1 indicates that PaO2 is probably between 100 and 200 mmHg. Thus, monitoring critically ill patients using the ORI, may help identifying when PaO2 is high and when FiO2 (or oxygen flows in non-intubated patients) may be reduced. This could help reducing the time with hyperoxia (i.e. PaO2 ≥100 mmHg or ≥80 mmHg).
The purpose of this feasibility study is to evaluate if the use of ORI can help to decrease length of moderate hyperoxia (PaO2>100mmHg) in critically ill patients, in comparison with monitoring the SpO2 only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monitoring with ORI + SpO2 | Experimental | Other: monitoring with ORI + SpO2Patients receive the regular monitoring with SpO2, but in this group, the ORI parameters is shown on the scope. Lower and upper SpO2 limits are prescribed for each patient. |
| monitoring with SpO2 | Other | Other: monitoring with SpO2Patients receive the regular monitoring; the ORI parameters is not shown (but it is recorded each time a blood gas is drown). Lower and upper SpO2 limits are prescribed for each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient hospitalized in ICU of Angers hospital
- Patient intubated and mechanically ventilated for an expected period of at least 2 days
- Inclusion is to achieve within 6 hours after admission (for admitted patients intubated ) or at the time of intubation (for non- intubated patients on admission )
Key exclusion criteria (1 listed)
- Pregnant Woman
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 |
|---|---|---|
| monitoring with ORI + SpO2Also: ORI groupIf ORI is equal to 0.00, the FiO2 (or oxygen flow) is not changed. if ORI is ≥ 0.01, Nurses must decrease the FiO2 (or oxygen flow) by 10%, until ORI is =0. if SpO2 is < lower individualized limit, FiO2 (or oxygen flow) is increased by 10%, if it happens twice, doctors are called. | Other | monitoring with ORI + SpO2 |
| monitoring with SpO2Also: Control groupIf SpO2 is below the upper individualized limit, the FiO2 (or oxygen flow) is not changed. If SpO2 is equal or above this limit, Nurses must reduce the FiO2 (or oxygen flow) by 10% every 10 minutes until SpO2 is ≤ upper individualized limit, with FiO2≥25 %. if SpO2 is < lower individualized limit, FiO2 (or oxygen flow) is increased by 10%, if it happens twice, doctors are called. | Other | monitoring with SpO2 |
Primary outcome
Percentage of days with moderate hyperoxia
Time frame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
The primary endpoint is the percentage of days with moderate hyperoxia. Moderate hyperoxia is defined by a PaO2> 100 mmHg - measured on blood gases obtained in usual practicePaO2 will be followed by the inclusion until the end of mechanical ventilation or D28 or ICU discharge. The percentage of days with moderate hyperoxia is (number of days of moderate hyperoxia / number of days of oxygen therapy) x100. The follow up will occurs from inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
11 secondary outcomes
Minimum and maximum daily FiO2
Time frame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Minimum and maximum daily PaO2
Time frame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Length of mechanical ventilation
Time frame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Number of day with PaO2 equal or above to 80 mmHg
Time frame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Number of hypoxemia episode
Time frame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Number of day without mechanical ventilation at D28
Time frame: inclusion to D28
Number of atelectasis episodes requiring specific medical care (that means fibro-aspiration or posture of patient)
Time frame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Average daily PaO2
Time frame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Number of moderate hypoxemia hours
Time frame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Maximum ORI values during pre-oxygenation before a endotracheal aspiration
Time frame: At each pre-oxugenation before a endotracheal aspiration occurs from inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Minimum SpO2 within 15 minutes following a endotracheal aspiration
Time frame: At each endotracheal aspiration occurs from inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Results publication: PubMed 31410497Lasocki S, Brochant A, Leger M, Gaillard T, Lemarie P, Gergaud S, Dupre P. ORI monitoring allows a reduction of time with hyperoxia in critically ill patients: the randomized control ORI2 study. Intensive Care Med. 2019 Nov;45(11):1661-1662. doi: 10.1007/s00134-019-05732-9. Epub 2019 Aug 13. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Intensive Care Units
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
RecruitingPhase 3
Ketamine Sedation in the ICU (KANINE) RCT
Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
Not yet recruitingPhase 3
Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients
Long-term Sedation for Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monitoring with ORI + SpO2 and monitoring with SpO2 in people with Intensive Care Units, run by University Hospital, Angers at 1 site in France.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 17 Nov 2020. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of days with moderate hyperoxia (time frame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge). 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 NCT02878460, 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 17 Nov 2020; AzTrials last refreshed its copy on 1 Nov 2026.