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

Not Applicable

Recruiting

• Conditions: Intensive Care Unit
• Interventions: Other: Unblinded ORI values; Other: Blinded ORI values

• Registration Number: NCT05867875
• Lead Sponsor: Nantes University Hospital

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

Study Timeline

• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Study Start: 2023-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 950

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (ORI)	Unblinded ORI values	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)
Standard of care (SoC) group	Blinded ORI values	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

Primary Outcome Measures

Name	Time	Method
Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI	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 Outcome Measures

Name	Time	Method
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	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
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	Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "Body Mass Index" subgroup

Trial Locations

Locations (21)

CHU Angers; 🇫🇷 Angers, France

CH Argenteuil; 🇫🇷 Argenteuil, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CH du Cotentin; 🇫🇷 Cherbourg, France

Anthony LEMIEUR; 🇫🇷 Cholet, France

APHP - Hôpital Louis Mourier; 🇫🇷 Colombes, France

CHU de Dijon; 🇫🇷 Dijon, France

CH d'Haguenau; 🇫🇷 Haguenau, France

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

CH de Versailles; 🇫🇷 Le Chesnay, France

CHR Lille - Hôpital Roger Salengro; 🇫🇷 Lille, France

HCL - Hôpital Edouard Herriot; 🇫🇷 Lyon, France

CHU Nantes; 🇫🇷 Nantes, France

CHU de Nice; 🇫🇷 Nice, France

CHR d'Orléans; 🇫🇷 Orléans, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

APHP - Hôpital Cochin; 🇫🇷 Paris, France

CHU de Rennes; 🇫🇷 Rennes, France

CH de Roanne; 🇫🇷 Roanne, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France

CHRU de Tours; 🇫🇷 Tours, France