Non-invasive Early Oxygen- Reserve-index (ORI) Determination to Prevent Hypoxaemia During Endotracheal Intubation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether ORI monitoring increases the lowest oxygen saturation level during the interval between the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) and the end of the second minute after successful ETI.

Detailed Description
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The trial population will be adults (18 years of age or older) who need endotracheal intubation while hospitalized in ICU

Official Title
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Impact of the Non-invasive Oxygen-reserve-index (ORI) Versus Standard of Care on Peripheral Oxygen Saturation (SpO2) During Endotracheal Intubation (ETI) in Intensive Care Unit: Randomised Superiority Multi-center 2 Arms, Open Trial

Conditions
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Intensive Care Unit

Intervention / Treatment
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* Other: Unblinded ORI values
* Other: Blinded ORI values


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU admission and need for ETI to allow mechanical ventilation Need for supplemental oxygen (via any device and at any flow rate) to obtain SpO2>97% Patient or next of kin informed about the study and having consented to participation of the patient in the study (patients with coma are unable to consent). If patient is no competent and no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with French law Patients affiliated to a social security system Exclusion Criteria: Patients participating in intubation research with an oxygenation endpoint will not be eligible for inclusion Fiberoptic intubation required according to physician in charge Contra-indications to laryngoscopy (e.g., unstable spinal lesion) Insufficient time to include and randomise the patient (e.g., because of cardiac arrest) Age <18 years Currently pregnant or breastfeeding Correctional facility inmate Under guardianship, curatorship or under protection of justice

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Consecutive Intensive Care Unit (ICU) patients requiring ETI will be randomly allocated to ETI with or without ORI monitoring before beginning of preoxygenation, with stratification by centre, expert or nonexpert intubator status (experts: ≥5 years' ICU experience, or ≥1 year ICU experience plus ≥2 years' anaesthesiology training), and Non-Invasive Ventilation (NIV) or others devices for preoxygenation. Randomisation will be via an electronic case-report form, using a balanced scheme with stratification as described above.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (ORI)<br>ORI and SpO2 monitoring values during preoxygenation of patients will be provided to investigator to determine anaesthesia induction initiation. Anesthesic induction is provided after 30 secondes at ORI > 0.6 and at least 2 min 30 of preoxygenation (so globaly 3 minutes of preoxygenation) | Other: Unblinded ORI values<br>* ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator<br>|
| Other: Standard of care (SoC) group<br>Only SpO2 values during preoxygenation of patients will be provided to investigator to determine anaesthesia induction initiation. Anesthesic induction is provided at least 3 min of preoxygenation | Other: Blinded ORI values<br>* ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI | Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in Experimental and Control groups | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether ORI monitoring increases the lowest oxygen saturation level according to local oximeter. | Lowest oxygen saturation monitored by local oximeter during ETI in Experimental and Control groups are compared to values monitored by Masimo Rad7 in same conditions | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI | 
| Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in Body Mass Index (<30 or ≥30) subgroup | Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in Body Mass Index subgroup | From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ORI, intensive care unit, ETI, Masimo Rad7