NCT04797520

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intubation Complication

Interventions

Type	Name	Description
DEVICE	Eko CORE Stethoscope	Eko CORE stethoscope will be used as a visual and auditory means of confirming placement of ETT
DEVICE	Point of care ultrasound	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

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2021-03-15
• Last updated: 2025-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study