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

NCT04797520 | Not Yet Recruiting FDA Device

• 1 other identifier: 60429
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  During assessment with Core-Eko augmented stethoscope auscultation (5min)

Study Arms (1)

Treatment

OTHER

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

Interventions

Eko CORE Stethoscope DEVICE

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

Treatment

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

Treatment

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Any patients under the age of 18
• Surgery requiring an ETT
• Consent/parental consent to

You may not qualify if:

• Possible difficult airway
• Significant lung pathology
• with any major cardiac anomaly

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

Related Publications (10)

• Kollef MH, Legare EJ, Damiano M. Endotracheal tube misplacement: incidence, risk factors, and impact of a quality improvement program. South Med J. 1994 Feb;87(2):248-54. doi: 10.1097/00007611-199402000-00020.

  PMID: 8115893 BACKGROUND

• Kerrey BT, Rinderknecht AS, Geis GL, Nigrovic LE, Mittiga MR. Rapid sequence intubation for pediatric emergency patients: higher frequency of failed attempts and adverse effects found by video review. Ann Emerg Med. 2012 Sep;60(3):251-9. doi: 10.1016/j.annemergmed.2012.02.013. Epub 2012 Mar 15.

  PMID: 22424653 BACKGROUND

• Jemmett ME, Kendal KM, Fourre MW, Burton JH. Unrecognized misplacement of endotracheal tubes in a mixed urban to rural emergency medical services setting. Acad Emerg Med. 2003 Sep;10(9):961-5. doi: 10.1111/j.1553-2712.2003.tb00652.x.

  PMID: 12957980 BACKGROUND

• Bissinger U, Lenz G, Kuhn W. Unrecognized endobronchial intubation of emergency patients. Ann Emerg Med. 1989 Aug;18(8):853-5. doi: 10.1016/s0196-0644(89)80211-2.

  PMID: 2757282 BACKGROUND

• Geisser W, Maybauer DM, Wolff H, Pfenninger E, Maybauer MO. Radiological validation of tracheal tube insertion depth in out-of-hospital and in-hospital emergency patients. Anaesthesia. 2009 Sep;64(9):973-7. doi: 10.1111/j.1365-2044.2009.06007.x.

  PMID: 19686482 BACKGROUND

• Brunel W, Coleman DL, Schwartz DE, Peper E, Cohen NH. Assessment of routine chest roentgenograms and the physical examination to confirm endotracheal tube position. Chest. 1989 Nov;96(5):1043-5. doi: 10.1378/chest.96.5.1043.

  PMID: 2509149 BACKGROUND

• Sivit CJ, Taylor GA, Hauser GJ, Pollack MM, Bulas DI, Guion CJ, Fearon T. Efficacy of chest radiography in pediatric intensive care. AJR Am J Roentgenol. 1989 Mar;152(3):575-7. doi: 10.2214/ajr.152.3.575.

  PMID: 2783812 BACKGROUND

• Dietrich KA, Strauss RH, Cabalka AK, Zimmerman JJ, Scanlan KA. Use of flexible fiberoptic endoscopy for determination of endotracheal tube position in the pediatric patient. Crit Care Med. 1988 Sep;16(9):884-7. doi: 10.1097/00003246-198809000-00013.

  PMID: 3402233 BACKGROUND

• Ramsingh D, Frank E, Haughton R, Schilling J, Gimenez KM, Banh E, Rinehart J, Cannesson M. Auscultation versus Point-of-care Ultrasound to Determine Endotracheal versus Bronchial Intubation: A Diagnostic Accuracy Study. Anesthesiology. 2016 May;124(5):1012-20. doi: 10.1097/ALN.0000000000001073.

  PMID: 26950708 BACKGROUND

• Behere S, Baffa JM, Penfil S, Slamon N. Real-World Evaluation of the Eko Electronic Teleauscultation System. Pediatr Cardiol. 2019 Jan;40(1):154-160. doi: 10.1007/s00246-018-1972-y. Epub 2018 Aug 31.

  PMID: 30171267 BACKGROUND

Study Officials

• Ban Tsui, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ban Tsui, MD

CONTACT

650-200-9107; bantsui@stanford.edu

Chynna Villanueva, BS, RN

CONTACT

6504986346; chynnav@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)