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

Nantes University Hospital21 sites in 1 country950 target enrollmentAugust 1, 2023

ConditionsIntensive Care Unit

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intensive Care Unit
Sponsor: Nantes University Hospital
Enrollment: 950
Locations: 21
Primary Endpoint: Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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

Registry

clinicaltrials.gov

Start Date

August 1, 2023

End Date

June 23, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI

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

Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in Experimental and Control groups

Secondary Outcomes

Determine whether ORI monitoring increases the lowest oxygen saturation level according to local oximeter.(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(From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI)