ORI2 : ORI for hyperOxia Reduction in ICU
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Percentage of days with moderate hyperoxia
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Number of day without mechanical ventilation at D28(inclusion to D28)
- Minimum and maximum daily FiO2(inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge)
- Minimum and maximum daily PaO2(inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge)
- Length of mechanical ventilation(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(inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge)
- Number of hypoxemia episode(inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge)
- Number of atelectasis episodes requiring specific medical care (that means fibro-aspiration or posture of patient)(inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge)
- Average daily PaO2(inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge)
- Number of moderate hypoxemia hours(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(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(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)