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

NCT05867875 | Completed DMC

• 1 other identifier: RC22_0506
• Study Type: interventional
• Target: 950
• Locations: 1 country
• Sites: 21

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.

Conditions

Intensive Care Unit

Keywords

ORI; intensive care unit; ETI; Masimo Rad7

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Other Outcomes (10)

• Determine whether ORI monitoring increases the lowest oxygen saturation level 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

  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

  From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI

Study Arms (2)

Experimental group (ORI)

EXPERIMENTAL

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

Standard of care (SoC) group

OTHER

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

Interventions

Unblinded ORI values OTHER

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

Experimental group (ORI)

Blinded ORI values OTHER

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

Standard of care (SoC) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• Patients affiliated to a social security system

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (21)

CHU Angers

Angers, 49933, France

Location

CH Argenteuil

Argenteuil, 95100, France

Location

CHU Bordeaux

Bordeaux, 33076, France

Location

CH du Cotentin

Cherbourg, France

Location

CH Cholet

Cholet, 49300, France

Location

APHP - Hôpital Louis Mourier

Colombes, 92700, France

Location

CHU de Dijon

Dijon, 21033, France

Location

CH d'Haguenau

Haguenau, 67500, France

Location

CHD Vendée

La Roche-sur-Yon, 85025, France

Location

CH de Versailles

Le Chesnay, 78150, France

Location

CHR Lille - Hôpital Roger Salengro

Lille, 59037, France

Location

HCL - Hôpital Edouard Herriot

Lyon, 69437, France

Location

CHU de Nantes

Nantes, 44093, France

Location

CHU de Nice

Nice, 06202, France

Location

CHR d'Orléans

Orléans, 45100, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

APHP - Hôpital Cochin

Paris, 75014, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CH de Roanne

Roanne, 43200, France

Location

CHRU de Strasbourg

Strasbourg, 67091, France

Location

CHRU de Tours

Tours, 37044, France

Location

Related Publications (1)

• Hille H, Le Thuaut A, Asfar P, Quelven Q, Mercier E, Le Meur A, Quenot JP, Lemiale V, Muller G, Cour M, Ferre A, Berge A, Curtiaud A, Touron M, Plantefeve G, Chakarian JC, Ricard JD, Colin G, Orieux A, Girardie P, Jozwiak M, Rouaud M, Juhel C, Reignier J, Lascarrou JB; CRICS-TRIGGERSEP Network. Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2. PLoS One. 2024 Sep 16;19(9):e0307723. doi: 10.1371/journal.pone.0307723. eCollection 2024.

  PMID: 39283873 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: During intubation procedure, blinded continuous monitoring of SpO2 and ORI (for control group) will be performed by appropriate monitor (Masimo Rad7) with data extraction at regular intervals. Oxygen saturation will be tracked during ETI by research nurse or assistant nurse dedicated to fill the eCRF. ORI evolution will not be provided to investigators in the standard of care group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Consecutive Intensive Care Unit (ICU) patients requiring ETI will be randomly allocated to ETI with or without ORI monitoring before beginning of preoxygenation, with stratification by centre, expert or nonexpert intubator status (experts: ≥5 years' ICU experience, or ≥1 year ICU experience plus ≥2 years' anaesthesiology training), and Non-Invasive Ventilation (NIV) or others devices for preoxygenation. Randomisation will be via an electronic case-report form, using a balanced scheme with stratification as described above.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 22, 2023
• Study Start: August 1, 2023
• Primary Completion: May 26, 2025
• Study Completion: June 23, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

FR (21)