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Completed

NCT Number: NCT05867875

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

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.

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Key information

Conditions

Intensive Care Unit

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unblinded ORI values

Other

ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator

Blinded ORI values

Other

ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator

Primary outcomes

  1. 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

  1. Determine whether ORI monitoring increases the lowest oxygen saturation level according to local oximeter.

    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 monitored by local oximeter during ETI in Experimental and Control groups are compared to values monitored by Masimo Rad7 in same conditions

  2. Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Body Mass Index (<30 or ≥30)" subgroup

    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 "Body Mass Index" subgroup

Other outcomes

  1. Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Reason for ETI (hypoxaemia/other)" subgroup

    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 "Reason for ETI (hypoxaemia/other)" subgroup

  2. Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Shock/No shock (at inclusion)" subgroup

    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 "Shock/No shock (at inclusion)" subgroup

  3. Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Difficult Intubation (yes or no)" subgroup

    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 "Difficult Intubation (yes or no)" subgroup

  4. Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "ORI threshold (<0.6 or ≥0.6)" subgroup

    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 "ORI threshold (<0.6 or ≥0.6)" subgroup

  5. Assess safety of ORI monitoring

    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

    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

  6. Assess efficacy of ORI monitoring on ICU mortality

    Time frame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days

    ICU mortality is assessed in Experimental and Control groups

  7. Assess efficacy of ORI monitoring on 28-day mortality

    Time frame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until day 28

    28-day mortality is assessed in Experimental and Control groups

  8. Assess efficacy of ORI monitoring on ICU stay length

    Time frame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days

    ICU stay length is assessed in Experimental and Control groups

  9. Assess efficacy of ORI monitoring on hospital stay length

    Time frame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from hospital or up to 28 days

    Hospital stay length is assessed in Experimental and Control groups

  10. Assess efficacy of ORI monitoring on Mean Cognitive Core at day 28 (modified Telephone Interview for Cognitive Status)

    Time frame: Day 28

    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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: NESOI-2

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 22, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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