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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT04797520
Status
Not Yet Recruiting

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Conditions

  • Intubation Complication

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 30, 2025
Status verified
Apr 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Other: Treatment
    All participants will have placement of ETT confirmed using both Core stethoscope and point-of-care ultrasound

Primary Outcome Measure

Localization of endotracheal tube placement by the presence/absence of lung pleural linings movement by ultrasound [ Time Frame: During assessment with point of care ultrasound (10min) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lucille Packard Children's HospitalPalo AltoCalifornia94304-

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