ORI2 : ORI for hyperOxia Reduction in ICU

University Hospital, Angers

Status: Completed

Conditions: Intensive Care Units

Treatments: Other: monitoring with SpO2; Other: monitoring with ORI + SpO2

Study type: Interventional

Funder types: Other

Identifiers

NCT02878460

CHU-P2016-04

2016-A01026-45 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

monitoring with ORI + SpO2

Experimental group

Description:

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.

Treatment:

Other: monitoring with ORI + SpO2

monitoring with SpO2

Other group

Description:

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.

Treatment:

Other: monitoring with SpO2