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ORI2 : ORI for hyperOxia Reduction in ICU

NCT02878460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-11-17

No results posted yet for this study

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

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-27
Primary Completion
2018-05-22
Completion
2018-05-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02878460 on ClinicalTrials.gov