NCT03600181: NESOI

Non-invasive Technology for Early Signal Detection of Hypoxemia With ORI During Intubation

Completed Last updated 4 May 2021

What this trial tests

trial testing RAD - 97 pulse co-oximeter in Intubation Complication in 50 participants. Completed in 22 July 2020.

Timeline

11 February 2019

Primary endpoint
22 July 2020

22 July 2020

Quick facts

Lead sponsor	Nantes University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	11 February 2019
Primary completion	22 July 2020
Estimated completion	22 July 2020
Sites	1 location across France

Drugs / interventions tested

• RAD - 97 pulse co-oximeter

Conditions studied

• Intubation Complication — all drugs for Intubation Complication →

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Intubation Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intubation of patients in the intensive care unit (ICU) carries a risk of potentially severe complications, including cardiac arrest. Hypoxemia is common in ICU patients requiring intubation, which must be performed rapidly to avoid aspiration, since the patient is usually not in the fasted state. Studies have assessed interventions designed to improve intubation success rates, such as routine neuromuscular blockade. Care bundles combined with training on simulators have improved the safety of intubation. Nevertheless, intubation in the ICU still carries higher morbidity and mortality rates compared to intubation in the operating room.

Preoxygenation is a cornerstone of safety for intubation in the ICU. Several recent trials have investigated different devices (non-rebreather mask, non-invasive ventilation, high flow nasal cannula, bag valve mask) with conflicting results. A main reason for those results is that efficiency of the preoxygenation period cannot be evaluated in the ICU in opposite to the operating room: gas monitoring are not available in ICU and even if it was the case, high flow demand from the patient, and agitation will make it inefficient. Additionally, desaturation is frequent (from 10% up to 50%) during intubation in ICU and lead to morbidity and mortality; so anticipation of desaturation is a major concern for ICU's physician because it's impacting care (face mask ventilation, early insertion of subglottic device). The oxygen reserve index (ORI) is a new parameter for monitoring oxygen reserve non-invasively.

In this context, the investigators purpose to analyze efficiency of preoxygenation and time allowed by ORI for medical interventions before hypoxemia during intubation in the ICU in a pilot observational study in our medical ICU in a university hospital.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oxygen reserve index for non-invasive early hypoxemia detection during endotracheal intubation in intensive care: the prospective observational NESOI study.
   Hille H, Le Thuaut A, Canet E, Lemarie J, et al · · 2021 · cited 10× · PMID 34406524 · DOI 10.1186/s13613-021-00903-8
2. Sanitary safety of the 2021 French Intensive Care Society medical conference: a case/control study.
   SRLF Trial Group. · · 2022 · cited 2× · PMID 35147794 · DOI 10.1186/s13613-022-00986-x