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

Not Applicable

Completed

• Conditions: Intensive Care Unit

• 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
• Primary Completion: 2025-05-26
• Study Completion: 2025-06-23
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: COMPLETED
• 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

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)

CH Cholet; 🇫🇷 Cholet, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU Angers; 🇫🇷 Angers, France

CH Argenteuil; 🇫🇷 Argenteuil, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CH du Cotentin; 🇫🇷 Cherbourg, France

APHP - Hôpital Louis Mourier; 🇫🇷 Colombes, France

CHU de Dijon; 🇫🇷 Dijon, France

CH d'Haguenau; 🇫🇷 Haguenau, France

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

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