ORI2 : ORI for hyperOxia Reduction in ICU

Study Overview
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Brief Summary
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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.

Official Title
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ORI2 : ORI for hyperOxia Reduction in ICU

Conditions
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Intensive Care Units

Intervention / Treatment
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* Other: monitoring with ORI + SpO2
* Other: monitoring with SpO2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ) Exclusion Criteria: Pregnant Woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: monitoring with ORI + SpO2<br>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. | Other: monitoring with ORI + SpO2<br>* 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.<br>* Other names: ORI group;|
| Other: monitoring with SpO2<br>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. | Other: monitoring with SpO2<br>* 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.<br>* Other names: Control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HYPEROXIA, MECHANICAL VENTILATION, OXYGEN RESERVE INDEX