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
Status: Completed
Location: See all (21) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CHU Angers
Angers
CH Argenteuil
Argenteuil
CHU Bordeaux
Bordeaux
CH du Cotentin
Cherbourg
CH Cholet
Cholet
APHP - Hôpital Louis Mourier
Colombes
CHU de Dijon
Dijon
CH d'Haguenau
Haguenau
CHD Vendée
La Roche-sur-yon
CH de Versailles
Le Chesnay
CHR Lille - Hôpital Roger Salengro
Lille
HCL - Hôpital Edouard Herriot
Lyon
CHU de Nantes
Nantes
CHU de Nice
Nice
CHR d'Orléans
Orléans
APHP - Hôpital Cochin
Paris
Hôpital Saint-Louis
Paris
CHU de Rennes
Rennes
CH de Roanne
Roanne
CHRU de Strasbourg
Strasbourg
CHRU de Tours
Tours
Time Frame
Start Date:2023-08-01
Completion Date:2025-06-23
Participants
Target number of participants:950
Treatments
Experimental: Experimental group (ORI)
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: Standard of care (SoC) group
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