Clinical trial NCT05867875: Non-invasive Early Oxygen- Reserve-index (ORI) Determination to Prevent Hypoxaemia During Endotracheal Intubation
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intensive Care Unit
Keywords: ORI
intensive care unit
ETI
Masimo Rad7
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI
timeFrame: 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:
measure: Determine whether ORI monitoring increases the lowest oxygen saturation level according to local oximeter.
timeFrame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
measure: Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Body Mass Index (<30 or ≥30)" subgroup
timeFrame: 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:
measure: Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Reason for ETI (hypoxaemia/other)" subgroup
timeFrame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
measure: Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Shock/No shock (at inclusion)" subgroup
timeFrame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
measure: Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Difficult Intubation (yes or no)" subgroup
timeFrame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
measure: Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "ORI threshold (<0.6 or ≥0.6)" subgroup
timeFrame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
measure: Assess safety of ORI monitoring
timeFrame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
measure: Assess efficacy of ORI monitoring on ICU mortality
timeFrame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days
measure: Assess efficacy of ORI monitoring on 28-day mortality
timeFrame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until day 28
measure: Assess efficacy of ORI monitoring on ICU stay length
timeFrame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days
measure: Assess efficacy of ORI monitoring on hospital stay length
timeFrame: From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from hospital or up to 28 days
measure: Assess efficacy of ORI monitoring on Mean Cognitive Core at day 28 (modified Telephone Interview for Cognitive Status)
timeFrame: Day 28
Locations:
city: Angers
country: France
facility: CHU Angers
city: Argenteuil
country: France
facility: CH Argenteuil
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Cherbourg
country: France
facility: CH du Cotentin
city: Cholet
country: France
facility: Anthony LEMIEUR
city: Colombes
country: France
facility: APHP - Hôpital Louis Mourier
city: Dijon
country: France
facility: CHU de Dijon
city: Haguenau
country: France
facility: CH d'Haguenau
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Chesnay
country: France
facility: CH de Versailles
city: Lille
country: France
facility: CHR Lille - Hôpital Roger Salengro
city: Lyon
country: France
facility: HCL - Hôpital Edouard Herriot
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU de Nice
city: Orléans
country: France
facility: CHR d'Orléans
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: APHP - Hôpital Cochin
city: Rennes
country: France
facility: CHU de Rennes
city: Roanne
country: France
facility: CH de Roanne
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Tours
country: France
facility: CHRU de Tours
Study officials:
References: