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

Last updated: February 25, 2025
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Unblinded ORI values

Blinded ORI values

Clinical Study ID

NCT05867875
RC22_0506
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 obtainSpO2>97%

  • Patient or next of kin informed about the study and having consented toparticipation of the patient in the study (patients with coma are unable toconsent). If patient is no competent and no next of kin can be contacted duringscreening for the study, trial inclusion will be completed as an emergency procedureby the ICU physician, in compliance with French law

  • Patients affiliated to a social security system

Exclusion

Exclusion Criteria:

  • Patients participating in intubation research with an oxygenation endpoint will notbe 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 cardiacarrest)

  • Age <18 years

  • Currently pregnant or breastfeeding

  • Correctional facility inmate

  • Under guardianship, curatorship or under protection of justice

Study Design

Total Participants: 950
Treatment Group(s): 2
Primary Treatment: Unblinded ORI values
Phase:
Study Start date:
August 01, 2023
Estimated Completion Date:
September 01, 2025

Study Description

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

Connect with a study center

  • CHU Angers

    Angers, 49933
    France

    Active - Recruiting

  • CH Argenteuil

    Argenteuil, 95100
    France

    Active - Recruiting

  • CHU Bordeaux

    Bordeaux, 33076
    France

    Active - Recruiting

  • CH du Cotentin

    Cherbourg,
    France

    Active - Recruiting

  • Anthony LEMIEUR

    Cholet, 49300
    France

    Active - Recruiting

  • APHP - Hôpital Louis Mourier

    Colombes, 92700
    France

    Active - Recruiting

  • CHU de Dijon

    Dijon, 21033
    France

    Active - Recruiting

  • CH d'Haguenau

    Haguenau, 67500
    France

    Active - Recruiting

  • CHD Vendée

    La Roche-sur-Yon, 85025
    France

    Active - Recruiting

  • CH de Versailles

    Le Chesnay, 78150
    France

    Active - Recruiting

  • CHR Lille - Hôpital Roger Salengro

    Lille, 59037
    France

    Active - Recruiting

  • HCL - Hôpital Edouard Herriot

    Lyon, 69437
    France

    Active - Recruiting

  • CHU Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • CHU de Nice

    Nice, 06202
    France

    Active - Recruiting

  • CHR d'Orléans

    Orléans, 45100
    France

    Active - Recruiting

  • APHP - Hôpital Cochin

    Paris, 75014
    France

    Active - Recruiting

  • Hôpital Saint-Louis

    Paris, 75010
    France

    Active - Recruiting

  • CHU de Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • CH de Roanne

    Roanne, 43200
    France

    Active - Recruiting

  • CHRU de Strasbourg

    Strasbourg, 67091
    France

    Active - Recruiting

  • CHRU de Tours

    Tours, 37044
    France

    Active - Recruiting

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