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

Not Applicable

Not yet recruiting

• Conditions: Intubation Complication
• Interventions: Device: Eko CORE Stethoscope; Device: Point of care ultrasound

• Registration Number: NCT04797520
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-18
• Study Start: 2023-12
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Any patients under the age of 18
• Surgery requiring an ETT
• Consent/parental consent to

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Exclusion Criteria

• Possible difficult airway
• Significant lung pathology
• with any major cardiac anomaly

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Eko CORE Stethoscope	All participants will have placement of ETT confirmed using both Core stethoscope and point-of-care ultrasound
Treatment	Point of care ultrasound	All participants will have placement of ETT confirmed using both Core stethoscope and point-of-care ultrasound

Primary Outcome Measures

Name	Time	Method
Localization of endotracheal tube placement by the presence/absence of breath sounds detected by Core-Eko augmented stethoscope	During assessment with Core-Eko augmented stethoscope auscultation (5min)	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).
Localization of endotracheal tube placement by the presence/absence of lung pleural linings movement by ultrasound	During assessment with point of care ultrasound (10min)	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.

Trial Locations

Locations (1)

Lucille Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States