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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04797520
Enrollment
100
Registered
2021-03-15
Start date
2025-11-30
Completion date
2026-11-30
Last updated
2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication

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.

Interventions

DEVICEEko CORE Stethoscope

Eko CORE stethoscope will be used as a visual and auditory means of confirming placement of ETT

DEVICEPoint 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

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Localization of endotracheal tube placement by the presence/absence of lung pleural linings movement by ultrasoundDuring 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.
Localization of endotracheal tube placement by the presence/absence of breath sounds detected by Core-Eko augmented stethoscopeDuring 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).

Countries

United States

Contacts

Primary ContactBan Tsui, MD
bantsui@stanford.edu650-200-9107
Backup ContactChynna Villanueva, BS, RN
chynnav@stanford.edu6504986346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026