An interventional study of Eko CORE Stethoscope and Point of care ultrasound in Intubation Complication, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
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.
Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
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Exclusion Criteria:
All participants will have placement of ETT confirmed using both Core stethoscope and point-of-care ultrasound
Device: Eko CORE Stethoscope · Device: Point of care ultrasound
Eko CORE stethoscope will be used as a visual and auditory means of confirming placement of ETT
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
Localization of endotracheal tube placement by the presence/absence of lung pleural linings movement by ultrasound
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.
Time frame: During assessment with point of care ultrasound (10min)
Localization of endotracheal tube placement by the presence/absence of breath sounds detected by Core-Eko augmented stethoscope
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).
Time frame: During assessment with Core-Eko augmented stethoscope auscultation (5min)
Plan to share: No
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