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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Intensive Care Unit

Treatments: Other: Blinded ORI values; Other: Unblinded ORI values

Study type: Interventional

Funder types: Other

Identifiers

NCT05867875

RC22_0506

Details and patient eligibility

About

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.

Full description

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

Enrollment: 950 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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950 participants in 2 patient groups

Experimental group (ORI)

Experimental group

Description:

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)

Treatment:

Other: Unblinded ORI values

Standard of care (SoC) group

Other group

Description:

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

Treatment:

Other: Blinded ORI values