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

NCT03600181 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2021-05-04

No results posted yet for this study

Summary

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.

Conditions

  • Intubation Complication

Interventions

DEVICE

RAD - 97 pulse co-oximeter

non-invasive sensor capable of measuring ORI (Rainbow® Sensor, R2-25, Revision L, Masimo Corp.) will be applied to the third or fourth finger on the contralateral side of the inflatable cuff for non-invasive blood pressure monitoring. Values from the RAD 97 monitor will be blinded to clinicians who perform intubation (clinical research nurse will be in charge of watching RAD 97 monitor)

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Jean-Baptiste Lascarrou, PH · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-11
Primary Completion
2020-07-22
Completion
2020-07-22
FDA Device
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03600181 on ClinicalTrials.gov