Non-invasive Early Oxygen- Reserve-index (ORI) Determination to Prevent Hypoxaemia During Endotracheal Intubation (NESOI-2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit
• Intervention / Treatment: Other: Unblinded ORI values; Other: Blinded ORI values

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 950
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Baptiste Lascarrou; Phone Number: +33 (0) 240087386; Email: jeanbaptiste.lascarrou@chu-nantes.fr

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • CHU Angers
    • Contact: Pierre ASFAR
  • Argenteuil, France, 95100
    • Recruiting
    • CH Argenteuil
    • Contact: Gaétan PLANTEFEVE
  • Bordeaux, France, 33076
    • Recruiting
    • CHU Bordeaux
    • Contact: Arthur ORIEUX
  • Cholet, France, 49300
    • Recruiting
    • Anthony LEMIEUR
    • Contact: Anthony LEMEUR
  • Colombes, France, 92700
    • Recruiting
    • APHP - Hôpital Louis Mourier
    • Contact: Jean-Damien RICARD
  • Dijon, France, 21033
    • Recruiting
    • CHU de Dijon
    • Contact: Jean-Pierre QUENOT
  • Haguenau, France, 67500
    • Recruiting
    • CH d'Haguenau
    • Contact: Asaël BERGER
  • La Roche-sur-Yon, France, 85025
    • Recruiting
    • CHD Vendee
    • Contact: Gwenael COLIN
  • Le Chesnay, France, 78150
    • Recruiting
    • CH de Versailles
    • Contact: alexis Ferre
  • Lille, France, 59037
    • Recruiting
    • CHR Lille - Hôpital Roger Salengro
    • Contact: Patrick GIRARDIE
  • Lyon, France, 69437
    • Recruiting
    • HCL - Hôpital Edouard Herriot
    • Contact: Martin COUR
  • Nice, France, 06202
    • Recruiting
    • Chu de Nice
    • Contact: Mathieu JOZWIAK
  • Orléans, France, 45100
    • Recruiting
    • CHR d'Orléans
    • Contact: Grégoire MULLER
  • Paris, France, 75010
    • Recruiting
    • Hôpital Saint-Louis
    • Contact: Virginie LEMIALE
  • Paris, France, 75014
    • Recruiting
    • APHP - Hôpital Cochin
    • Contact: Jean-Paul MIRA
  • Rennes, France, 35033
    • Recruiting
    • Chu de Rennes
    • Contact: Quentin QUELVEN
  • Roanne, France, 43200
    • Recruiting
    • CH de Roanne
    • Contact: Jean-Charles CHAKARIAN
  • Strasbourg, France, 67091
    • Recruiting
    • CHRU de Strasbourg
    • Contact: Hamid MERDJI
  • Tours, France, 37044
    • Recruiting
    • CHRU de Tours
    • Contact: Emmanuelle MERCIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of care (SoC) group; 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; ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator
Experimental: Experimental group (ORI); 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; ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Reason for ETI (hypoxaemia/other)" subgroup	Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "Reason for ETI (hypoxaemia/other)" subgroup	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 "Shock/No shock (at inclusion)" subgroup	Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "Shock/No shock (at inclusion)" subgroup	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 "Difficult Intubation (yes or no)" subgroup	Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "Difficult Intubation (yes or no)" subgroup	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 "ORI threshold (<0.6 or ≥0.6)" subgroup	Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "ORI threshold (<0.6 or ≥0.6)" subgroup	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Assess safety of ORI monitoring	Occurrence of at least one severe life-threatening complication (death, cardiac arrest, arterial systolic pressure <90 mmHg, and/or SpO2<80%) and occurrence of each are assessed in Experimental and Control group	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Assess efficacy of ORI monitoring on ICU mortality	ICU mortality is assessed in Experimental and Control groups	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days
Assess efficacy of ORI monitoring on 28-day mortality	28-day mortality is assessed in Experimental and Control groups	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until day 28
Assess efficacy of ORI monitoring on ICU stay length	ICU stay length is assessed in Experimental and Control groups	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days
Assess efficacy of ORI monitoring on hospital stay length	Hospital stay length is assessed in Experimental and Control groups	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from hospital or up to 28 days
Assess efficacy of ORI monitoring on Mean Cognitive Core at day 28 (modified Telephone Interview for Cognitive Status)	Mean Cognitive Score at day 28 using modified Telephone Interview for Cognitive Status is assessed in Experimental and Control groups Values range from 0 to 43, with higher scores indicating better cognition	Day 28

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 9, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: intensive care unit; ETI; ORI; Masimo Rad7
• Other Study ID Numbers: RC22_0506

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No