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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chynna Villanueva, BS, RN
- Phone Number: 6504986346
- Email: chynnav@stanford.edu
Study Contact Backup
- Name: Ban Tsui, MD
- Phone Number: 650-200-9107
- Email: bantsui@stanford.edu
Study Locations
-
-
California
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Palo Alto, California, United States, 94304
- Lucille Packard Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Treatment
All participants will have placement of ETT confirmed using both Core stethoscope and point-of-care ultrasound
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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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.
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During assessment with point of care ultrasound (10min)
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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). |
During assessment with Core-Eko augmented stethoscope auscultation (5min)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ban Tsui, MD, Stanford University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 60429
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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