ORI2 : ORI for hyperOxia Reduction in ICU

NCT02878460 | Completed

• 2 other identifiers: CHU-P2016-042016-A01026-45
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of days with moderate hyperoxia

  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

  inclusion to the end of mechanical ventilation or Day 28 if patient is still mechanically ventilated or ICU discharge

Secondary Outcomes (11)

• 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

Study Arms (2)

monitoring with ORI + SpO2

EXPERIMENTAL

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.

Other: monitoring with ORI + SpO2

monitoring with SpO2

OTHER

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.

Other: monitoring with SpO2

Interventions

monitoring with ORI + SpO2 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.

Also known as: ORI group

monitoring with ORI + SpO2

monitoring with SpO2 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.

Also known as: Control group

monitoring with SpO2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient hospitalized in ICU of Angers hospital
• Patient intubated and mechanically ventilated for an expected period of at least 2 days

You may not qualify if:

• Pregnant Woman

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Chu Angers

Angers, 49000, France

Location

Related Publications (1)

• 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.

  PMID: 31410497 RESULT

MeSH Terms

Conditions

Hyperoxia

Interventions

Oxygen Saturation; Control Groups

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metabolism; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 25, 2016
• Study Start: April 27, 2017
• Primary Completion: May 22, 2018
• Study Completion: May 22, 2018
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)