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

Intensive Care Unit Clinical Trial

— NESOI-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867875
• Other study ID #: RC22_0506
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: Nantes University Hospital
• Contact: Jean-Baptiste Lascarrou
• Phone: +33 (0) 240087386
• Email: jeanbaptiste.lascarrou[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 950
• Est. completion date: March 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care Unit

Intervention

Other:
• Unblinded ORI values
ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator
• Blinded ORI values
ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CH Argenteuil	Argenteuil
France	CHU Bordeaux	Bordeaux
France	CH du Cotentin	Cherbourg
France	Anthony LEMIEUR	Cholet
France	APHP - Hôpital Louis Mourier	Colombes
France	CHU de Dijon	Dijon
France	CH d'Haguenau	Haguenau
France	CHD Vendée	La Roche-sur-Yon
France	CH de Versailles	Le Chesnay
France	CHR Lille - Hôpital Roger Salengro	Lille
France	HCL - Hôpital Edouard Herriot	Lyon
France	CHU de Nice	Nice
France	CHR d'Orléans	Orléans
France	APHP - Hôpital Cochin	Paris
France	Hôpital Saint-Louis	Paris
France	CHU de Rennes	Rennes
France	CH de Roanne	Roanne
France	CHRU de Strasbourg	Strasbourg
France	CHRU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Reason for ETI (hypoxaemia/other)" subgroup	Lowest oxygen saturation is monitored by Masimo Rad7 oximeter 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
Other	Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Shock/No shock (at inclusion)" subgroup	Lowest oxygen saturation is monitored by Masimo Rad7 oximeter 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
Other	Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Difficult Intubation (yes or no)" subgroup	Lowest oxygen saturation is monitored by Masimo Rad7 oximeter 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
Other	Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "ORI threshold (<0.6 or =0.6)" subgroup	Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "ORI threshold (<0.6 or =0.6)" 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	Assess safety of ORI monitoring	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	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Other	Assess efficacy of ORI monitoring on ICU mortality	ICU mortality is assessed in Experimental and Control groups	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days
Other	Assess efficacy of ORI monitoring on 28-day mortality	28-day mortality is assessed in Experimental and Control groups	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until day 28
Other	Assess efficacy of ORI monitoring on ICU stay length	ICU stay length is assessed in Experimental and Control groups	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from intensive care unit or up to 28 days
Other	Assess efficacy of ORI monitoring on hospital stay length	Hospital stay length is assessed in Experimental and Control groups	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until discharge from hospital or up to 28 days
Other	Assess efficacy of ORI monitoring on Mean Cognitive Core at day 28 (modified Telephone Interview for Cognitive Status)	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	Day 28
Primary	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	Determine whether ORI monitoring increases the lowest oxygen saturation level according to local oximeter.	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	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI
Secondary	Determine whether ORI monitoring increases the lowest oxygen saturation level during ETI in "Body Mass Index (<30 or =30)" subgroup	Lowest oxygen saturation is monitored by Masimo Rad7 oximeter during ETI in "Body Mass Index" subgroup	From the first laryngoscopy (defined as introduction of the laryngoscope into the mouth) until the end of the second minute after successful ETI