Intubation ComplicationNCT04797520
Diagnostic Accuracy of Core Stethoscope Auscultation vs. Point of Care Ultrasound in Placement of Endotracheal Tube
A study testing Eko CORE Stethoscope and Point of care ultrasound in people with Intubation Complication, run by Stanford University at 1 site in United States.
Trial 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%)… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Eko CORE Stethoscope and Point of care ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Any patients under the age of 18
- Surgery requiring an ETT
- Consent/parental consent to
Who cannot join
- Possible difficult airway
- Significant lung pathology
- with any major cardiac anomaly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lucille Packard Children's Hospital
Palo Alto, California, 94304
About this study
Official title: 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.
- Conditions
- Intubation Complication
- Being tested
- Eko CORE Stethoscope, Point of care ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eko CORE StethoscopeDevice
Eko CORE stethoscope will be used as a visual and auditory means of confirming placement of ETT
Point of care ultrasoundDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | All participants will have placement of ETT confirmed using both Core stethoscope and point-of-care ultrasound Receives: Device: Eko CORE Stethoscope; Device: Point of care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: During assessment with Core-Eko augmented stethoscope auscultation (5min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study startNov 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Ho Ban Tsui, Stanford University
- Investigators
- Ban Tsui, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797520
- Sponsor's protocol ID
- 60429
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2021
- Last updated
- 4 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 8115893Kerrey 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.
PubMed 22424653Jemmett 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.
PubMed 12957980Bissinger 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.
PubMed 2757282Geisser 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.
PubMed 19686482Brunel 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.
PubMed 2509149Sivit 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.
PubMed 2783812Dietrich 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.
PubMed 3402233Ramsingh 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.
PubMed 26950708Behere 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.
PubMed 30171267
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Diagnostic Accuracy of Core Stethoscope Auscultation vs. Point of Care Ultrasound in Localizing Correct Placement of Endotracheal Tube
- ClinicalTrials.gov ID
- NCT04797520
- Acronym / sponsor ID
- 60429
- Conditions
- Intubation Complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: Eko CORE Stethoscope, Device: Point of care ultrasoundAll participants will have placement of ETT confirmed using both Core stethoscope and point-of-care ultrasound |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Any patients under the age of 18
- Surgery requiring an ETT
- Consent/parental consent to
Key exclusion criteria (3 listed)
- Possible difficult airway
- Significant lung pathology
- with any major cardiac anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eko CORE StethoscopeEko CORE stethoscope will be used as a visual and auditory means of confirming placement of ETT | Device | Treatment |
| Point of care ultrasoundPoint of care ultrasound will be used as a means of confirming placement of ETT. This is the "gold standard" used in standard of care | Device | Treatment |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Background: PubMed 8115893Kollef 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.
- Background: PubMed 22424653Kerrey 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.
- Background: PubMed 12957980Jemmett 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.
- Background: PubMed 2757282Bissinger 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.
- Background: PubMed 19686482Geisser 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.
- Background: PubMed 2509149Brunel 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.
- Background: PubMed 2783812Sivit 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.
- Background: PubMed 3402233Dietrich 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.
- Background: PubMed 26950708Ramsingh 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.
- Background: PubMed 30171267Behere 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ban Tsui, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eko CORE Stethoscope and Point of care ultrasound in people with Intubation Complication, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ban Tsui, MD (650-200-9107, bantsui@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04797520, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.