Core Stethoscope vs. Ultrasound for Endotracheal Intubation

Overseen By Ban Tsui, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Difficult airway, Lung pathology, Cardiac anomaly

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Eko CORE Stethoscope and Point of care ultrasound for endotracheal intubation?

Research shows that point-of-care ultrasound (POCUS) can be a helpful tool for confirming the correct placement of breathing tubes, with studies indicating it can accurately identify incorrect placements. Additionally, training programs have successfully improved the ability of medical staff to use ultrasound for this purpose, suggesting its potential effectiveness in clinical settings. ^{1 2 3 4 5}

Is it safe to use ultrasound for confirming endotracheal tube placement?

The studies suggest that using ultrasound to confirm endotracheal tube placement is generally safe, as it is a non-invasive method and has been used in various medical settings without reported safety issues. ^{1 2 3 5 6}

How does the treatment using the Eko CORE Stethoscope and point of care ultrasound for endotracheal intubation differ from other treatments?

The Eko CORE Stethoscope and point of care ultrasound offer a unique approach to endotracheal intubation by providing real-time audio and visual feedback, which can enhance accuracy and speed compared to traditional methods that rely solely on physical examination and visual confirmation. ^{7 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

Ban Tsui, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for patients of any age needing an endotracheal tube (ETT) for surgery. They must consent or have parental consent if under 18. It's not for those with major heart problems, significant lung disease, or anticipated difficult airway.

Inclusion Criteria

Consent/parental consent to

I need surgery that requires being put on a breathing machine.

I am under 18 years old.

Exclusion Criteria

I have a significant heart condition.

I have a serious lung condition.

There is a risk that it might be hard to breathe during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Assessment

Participants undergo assessment of endotracheal tube placement using Core stethoscope and point-of-care ultrasound

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any immediate complications following the assessment

1 week

Treatment Details

Interventions

• Eko CORE Stethoscope
• Point of care ultrasound

Trial Overview The study compares the accuracy of a new Core stethoscope and point-of-care ultrasound in confirming correct ETT placement during surgery to avoid complications like respiratory failure.

Participant Groups

Group I: Treatment Experimental Treatment 2 Interventions

All participants will have placement of ETT confirmed using both Core stethoscope and point-of-care ultrasound

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Lung ultrasound (LUS) is a safe and non-invasive method that can effectively help assess the correct positioning of endotracheal tubes (ETT) during the INSURE procedure in newborns with respiratory distress syndrome.

In a study involving 12 newborns, LUS successfully aided in correctly repositioning the ETT in two cases, demonstrating its utility in clinical settings where traditional x-rays are not performed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lung ultrasound as a tool to guide the administration of surfactant in premature neonates]. Rodríguez-Fanjul, J., Balcells Esponera, C., Moreno Hernando, J., et al.[2017]

In a study of 57 patients, right subcostal ultrasound demonstrated a high sensitivity of 92% for identifying esophageal intubations, making it a reliable tool for confirming correct endotracheal tube placement.

The ultrasound also showed a specificity of 96% for tracheal intubations, indicating that it can effectively differentiate between correct and incorrect intubation in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary confirmation of endotracheal tube position by diaphragm motion in right subcostal ultrasound view. Hosseini, JS., Talebian, MT., Ghafari, MH., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Teaching Flight Nurses Ultrasonographic Evaluation of Esophageal Intubation and Pneumothorax. [2020]

2. Spain pubmed.ncbi.nlm.nih.gov

[Lung ultrasound as a tool to guide the administration of surfactant in premature neonates]. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Temporal comparison of ultrasound vs. auscultation and capnography in verification of endotracheal tube placement. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Transtracheal 2-d ultrasound for identification of esophageal intubation. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Defining the learning curve of point-of-care ultrasound for confirming endotracheal tube placement by emergency physicians. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Secondary confirmation of endotracheal tube position by diaphragm motion in right subcostal ultrasound view. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Root canal preparation with Endo-Eze AET: changes in root canal shape assessed by micro-computed tomography. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Stereomicroscopic evaluation of canal shape following hand, sonic, and ultrasonic instrumentation. [2019]

9. Brazil pubmed.ncbi.nlm.nih.gov

Micro-CT assessment of two different endodontic preparation systems. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Evaluation of the accuracy of three electronic apex locators using glass tubules. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Histological evaluation of ultrasonic and sonic instrumentation of curved root canals. [2006]