ORI2 : ORI for hyperOxia Reduction in ICU

NCT ID: NCT02878460

Last Updated: 2020-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-27
• Study Completion Date: 2018-05-22

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.

Conditions

Intensive Care Units

Keywords

HYPEROXIA; MECHANICAL VENTILATION; OXYGEN RESERVE INDEX

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

monitoring with ORI + SpO2

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.

Group Type: EXPERIMENTAL

monitoring with ORI + SpO2

Intervention Type: OTHER

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 SpO2

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.

Group Type: OTHER

monitoring with SpO2

Intervention Type: OTHER

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.

Interventions

monitoring with ORI + SpO2

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.

Intervention Type: OTHER

monitoring with SpO2

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.

Intervention Type: OTHER

Other Intervention Names

ORI group; Control group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Angers

Angers, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 31410497 (View on PubMed)

Other Identifiers

2016-A01026-45

Identifier Type: REGISTRY

Identifier Source: secondary_id

CHU-P2016-04

Identifier Type: -

Identifier Source: org_study_id