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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether the Eko CORE Stethoscope can assist doctors in correctly placing a breathing tube in the throat. Misplacing the tube can cause serious issues, such as breathing difficulties or lung collapse. Although current methods like chest X-rays are accurate, they are slow and costly. The trial will compare the stethoscope to a quick ultrasound method to evaluate their effectiveness. It seeks patients under 18 who require a breathing tube for surgery and do not have major lung or heart issues. As an unphased trial, this study provides an opportunity to contribute to medical advancements that could enhance patient care.

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 prior data suggests that these techniques are safe for verifying endotracheal tube placement?

Research has shown that both the Eko CORE Stethoscope and point-of-care ultrasound are generally safe in medical settings. The Eko CORE Stethoscope effectively detects heart murmurs without known side effects, making it a well-accepted tool in practice.

Point-of-care ultrasound is highly accurate and does not involve surgery or breaking the skin. Studies have demonstrated a 97.5% success rate in confirming the correct placement of breathing tubes. This technique is safe and commonly used, especially in emergencies.

Both tools are non-invasive, meaning they don't require surgery or breaking the skin, which helps reduce risks. While the stethoscope is less studied for tube placement, it has proven safe for other uses. The ultrasound is already trusted for confirming tube placement, with a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to confirm the placement of an endotracheal tube (ETT) during intubation. Unlike the traditional method that often relies solely on a stethoscope to listen for breath sounds, this trial compares the use of the Eko CORE Stethoscope with point-of-care ultrasound. The Eko CORE Stethoscope is unique because it combines digital technology with traditional auscultation, potentially offering more accurate sound enhancement and visualization. Meanwhile, ultrasound provides a visual confirmation of the tube's placement, which could reduce the risk of misplacement. This trial could lead to more reliable and efficient methods for ensuring safe intubation.

What evidence suggests that the Core stethoscope and point-of-care ultrasound are effective for verifying endotracheal tube placement?

This trial will compare the effectiveness of the Eko CORE Stethoscope and point-of-care ultrasound for confirming endotracheal tube (ETT) placement. Research has shown that point-of-care ultrasound is highly effective for verifying correct ETT placement, with studies indicating 98.2% accuracy in confirming the tube is in the windpipe and 100% accuracy in detecting esophageal misplacement. This makes it very reliable for ensuring proper tube placement. In contrast, the Eko CORE Stethoscope is effective at identifying heart issues but has not yet been tested for ETT placement. Researchers are exploring this new application, but there is no solid evidence yet on its effectiveness for this purpose. ^{1 2 3 6 7}

Who Is on the Research Team?

Ban Tsui, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-11-2021-0ba69

Core Stethoscope vs. Ultrasound for Endotracheal Intubation Tele-auscultation system via Core stethoscope (Eko, Berkeley, CA) has been shown to be effective in identifying pathologic heart murmur (10) yet its potential ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04797520?tab=history&a=2

Record History | ver. 2: 2021-04-01 | NCT04797520 Tele-auscultation system via Core stethoscope (Eko, Berkeley, CA) has been shown to be effective in identifying pathologic heart murmur (10) yet its ...

3. med.stanford.edu med.stanford.edu/mosslab/research/_jcr_content/main/clinicaltrials.html?ctid=NCT04797520&conditionId=&serviceLineId=&condition=&alpha=d

Diagnostic Accuracy of Core Stethoscope Auscultation vs ... Tele-auscultation system via Core stethoscope (Eko, Berkeley, CA) has been shown to be effective in identifying pathologic heart murmur (10) yet its potential ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11078172/

Novel Cost-Effective Model for Training Post-intubation ... This study introduces a cost-effective and easily accessible training model for confirming ETT placement using ultrasound, aiming to improve training and ...

5. ekohealth.com ekohealth.com/blogs/newsroom/study-demonstrates-ai-assisted-detection-of-reduced-ejection-fraction?srsltid=AfmBOopZJpDe_OmtTAptMzbS1qJ9ib55nfHPeqIp8IAEusSikRtWSpAs

Study Demonstrates AI-Assisted Detection of Reduced ... The study shows Eko's AI model uses heart sound and ECG data to detect reduced ejection fraction (EF) with strong predictive performance, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8204844/

Practice, Outcomes, and Complications of Emergent ... For patients with COVID-19 who undergo emergency endotracheal intubation, data are limited regarding the practice, outcomes, and complications

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04317521?term=AREA%5BConditionSearch%5D(Heart%20murmurs)&rank=2

A Prospective Study Investigating the Use of the Eko CORE ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...