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

NCT03600181 | Completed FDA Device

• 1 other identifier: RC18_0181
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preoxygenation; Hypoxemia; ICU; ORI; Orotracheal intubation

Outcome Measures

Primary Outcomes (1)

• Assess whether the ORI index allows earlier detection of hypoxemia than with SpO2

  Average delay between drop of ORI and drop of SpO2 will be estimate with 95% confidence interval

  Participants will be followed for the duration of intubation process, an expected average of 10 minutes.

Secondary Outcomes (1)

• Measuring prognosis value of ORI during preoxygenation for occurrence of hypoxemia during intubation process

  Participants will be followed for the duration of intubation process, an expected average of 10 minutes.

Study Arms (1)

orotracheal intubation

Patients admitted in ICU and planned to be intubated. Non-invasive sensor capable of measuring ORI (RAD - 97 pulse co-oximeter; 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.

Device: RAD - 97 pulse co-oximeter

Interventions

RAD - 97 pulse co-oximeter DEVICE

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)

orotracheal intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted in ICU and planned to be intubated. Recruitment will be done in the Medical ICU of Nantes University Hospital. The study plans to include 50 patients admitted to intensive care and requiring a tracheal intubation procedure, after the provision of the informational letter and collection of non-opposition from the patient or responsible party, or through the emergency inclusion process. In the latter two cases, the non-opposition of the patient will be collected retrospectively after reading the informational letter.

You may qualify if:

• ICU admission and need for orotracheal intubation (OTI) to allow mechanical ventilation.
• SpO2/FiO2 ratio upper than 214 (the SpO2/FiO2 ratio will be measured under NIV or HFNC(high flow nasal cannula), and calculated under standard oxygen as follows : FiO2 = 0.21+oxygen flow rate×0.03).

You may not qualify if:

• Patients will be excluded from the analysis if :
• Failure of computer used to record ORI.
• No ORI values displayed.
• ORI remaining constant at 1 throughout the monitoring.
• SpO2 will stay under 97% during intubation process.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (1)

• Hille H, Le Thuaut A, Canet E, Lemarie J, Crosby L, Ottavy G, Garret C, Martin M, Seguin A, Lamouche-Wilquin P, Morin J, Zambon O, Miaihle AF, Reignier J, Lascarrou JB. Oxygen reserve index for non-invasive early hypoxemia detection during endotracheal intubation in intensive care: the prospective observational NESOI study. Ann Intensive Care. 2021 Jul 17;11(1):112. doi: 10.1186/s13613-021-00903-8.

  PMID: 34406524 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Baptiste Lascarrou, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: July 26, 2018
• Study Start: February 11, 2019
• Primary Completion: July 22, 2020
• Study Completion: July 22, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

FR (1)