NCT05867875

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 950 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Intensive Care Unit

Interventions

Type	Name	Description
OTHER	Unblinded ORI values	ORI and SpO2 monitoring will be performed using Masimo Rad 7 and both values will be provided to investigator
OTHER	Blinded ORI values	ORI and SpO2 monitoring will be performed using Masimo Rad 7 and only SpO2 values will be provided to investigator

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-05-26
• Completion: 2025-06-23
• First posted: 2023-05-22
• Last updated: 2025-08-05

Locations

21 sites across 1 country: France