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NCT Number: NCT04797520

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

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.

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Key information

Conditions

Intubation Complication

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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)

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 stethoscope

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ban Tsui, MD

CONTACT

[email protected]

650-200-9107

Chynna Villanueva, BS, RN

CONTACT

[email protected]

6504986346

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 15, 2021
Registry last updated: May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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