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

Nantes University Hospital950 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

950

Conditions

Intensive Care Unit

Interventions

Unblinded ORI valuesOTHER

ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator

Blinded ORI valuesOTHER

ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

CHU Angers

Angers, France

CH Argenteuil

Argenteuil, France

Outcomes

Primary Outcomes

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

Time frame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI

Secondary Outcomes

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

Time frame: 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

Time frame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI

Data from ClinicalTrials.gov

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