Diagnostic Accuracy of Core Stethoscope Auscultation vs. Point of Care Ultrasound in Placement of Endotracheal Tube

Study Overview
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Brief Summary
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Misplacement of endotracheal tube (ETT) can have devastating complications for patients, some of which include respiratory failure, atelectasis, and pneumothorax. There are a number of ways to verify the correct placement of ETT, with the stethoscope auscultation being commonly used despite its low accuracy (60-65%) in distinguishing tracheal from bronchial intubation (4-6). The gold standard techniques include Chest X Ray or fiberoptic bronchoscope (7-8), with a recent study showing point-of-care ultrasound. However, these techniques are expensive, time-consuming, often not readily available and require substantial training before users can reliably utilize them. Given intubation is often performed in urgent clinical settings, a technique that can reliably yet efficiently localize ETT would be beneficial. Tele-auscultation system via Core stethoscope (Eko, Berkeley, CA) has been shown to be effective in identifying pathologic heart murmur (10) yet its potential use in guiding the correct placement of ETT has not been explored. We set out to study the suitability of Core stethoscope in detecting the correct placement of ETT.

Official Title
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Assessing Diagnostic Accuracy of Core Stethoscope Auscultation vs. Point of Care Ultrasound in Localizing Correct Placement of Endotracheal Tube

Conditions
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Intubation Complication

Intervention / Treatment
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* Device: Eko CORE Stethoscope
* Device: Point of care ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patients under the age of 18 Surgery requiring an ETT Consent/parental consent to Exclusion Criteria: Possible difficult airway Significant lung pathology with any major cardiac anomaly

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>All participants will have placement of ETT confirmed using both Core stethoscope and point-of-care ultrasound | Device: Eko CORE Stethoscope<br>* Eko CORE stethoscope will be used as a visual and auditory means of confirming placement of ETT<br>Device: Point of care ultrasound<br>* Point of care ultrasound will be used as a means of confirming placement of ETT. This is the gold standard used in standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Localization of endotracheal tube placement by the presence/absence of lung pleural linings movement by ultrasound | Ultrasound placed vertically on the anterior chest of a patient will assess for the presence/absence of the horizontal movement of the two lung pleural linings with respiration. | During assessment with point of care ultrasound (10min) | 
| Localization of endotracheal tube placement by the presence/absence of breath sounds detected by Core-Eko augmented stethoscope | Presence of breath sounds will be assessed and recorded using Core-Eko augmented stethoscope, in conjunction with the smartphone interface over Bluetooth, by auscultating patient's chest. The technology will display breath sounds as a visual soundwave on the smartphone. As a result, this will be used to determine location of endotracheal tube (for example, if breath sounds absent in the left lung, we would infer that the tube is in the right bronchus). | During assessment with Core-Eko augmented stethoscope auscultation (5min) |