Clinical trial NCT02878460: ORI2 : ORI for hyperOxia Reduction in ICU
Official title: ORI2 : ORI for hyperOxia Reduction in ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Units
Keywords: HYPEROXIA
MECHANICAL VENTILATION
OXYGEN RESERVE INDEX
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-08-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of days with moderate hyperoxia
timeFrame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
Secondary outcomes:
measure: Minimum and maximum daily FiO2
timeFrame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
measure: Minimum and maximum daily PaO2
timeFrame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
measure: Length of mechanical ventilation
timeFrame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
measure: Number of day with PaO2 equal or above to 80 mmHg
timeFrame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
measure: Number of hypoxemia episode
timeFrame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
measure: Number of day without mechanical ventilation at D28
timeFrame: inclusion to D28
measure: Number of atelectasis episodes requiring specific medical care (that means fibro-aspiration or posture of patient)
timeFrame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
measure: Average daily PaO2
timeFrame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
measure: Number of moderate hypoxemia hours
timeFrame: inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge
measure: Maximum ORI values during pre-oxygenation before a endotracheal aspiration
timeFrame: 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
measure: Minimum SpO2 within 15 minutes following a endotracheal aspiration
timeFrame: 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
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
Study officials:
References:
citation: 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.