USD-ETT for Airway Management

Overseen By Andrea Les, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: John R. Charpie

Disqualifiers: Airway abnormality, Tracheostomy, Ventilator-dependent, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a new type of breathing tube, visible with ultrasound, helps doctors place it more accurately. The goal is to ensure the tube reaches the correct position and depth when a patient undergoes anesthesia for heart procedures. Individuals scheduled for a heart procedure with general anesthesia who require a breathing tube may be suitable candidates for this trial.

As an unphased trial, this study allows patients to contribute to advancements in medical procedures and improve outcomes for future heart surgery patients.

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 this device is safe for airway management?

Research shows that ultrasound technology can help place breathing tubes more accurately. Studies have found that ultrasound can confirm correct tube placement and quickly identify any errors.

The ultrasound-detectable endotracheal tube (USD-ETT) aims to improve this process. Although specific safety reports for this device are not yet available, ultrasound is widely used and well-tolerated in medical settings, including airway management.

Labeling the trial as "Not Applicable" for phases likely indicates it tests the device's effectiveness rather than its safety. Since ultrasound is already a trusted tool in healthcare, the USD-ETT should be safe to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ultrasound-detectable endotracheal tube (USD-ETT) because it offers a new way to manage airways with greater precision. Unlike traditional endotracheal tubes, which rely on X-rays or manual checks, the USD-ETT can be easily identified using ultrasound. This feature allows for quicker and more accurate positioning, minimizing potential complications during intubation. Additionally, the use of ultrasound reduces exposure to radiation, making the procedure safer for both patients and medical staff.

What evidence suggests that this device is effective for airway management?

Research has shown that ultrasound, which uses sound waves to create images, can effectively confirm the correct placement of a breathing tube, especially in challenging situations like cardiac arrest. Studies have found that ultrasound excels at detecting when a tube mistakenly enters the esophagus, rather than the trachea. This helps prevent serious complications by ensuring the tube is correctly placed in the windpipe. In this trial, participants will receive an ultrasound-detectable endotracheal tube (USD-ETT), designed for easier visualization with ultrasound, ensuring more accurate placement. This could enhance the safety and reliability of breathing tube insertion. ^{1 3 6 7 8}

Who Is on the Research Team?

John Charpie, MD, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for patients scheduled for cardiac catheterization needing general anesthesia with endotracheal intubation. It's not suitable for those with tracheostomies, allergies to the tube materials, airway abnormalities, or who are already intubated or enrolled in another trial.

Inclusion Criteria

I am scheduled for a heart procedure that will require me to be put to sleep and have a breathing tube.

Exclusion Criteria

I have a tracheostomy.

I am expected to remain on a breathing machine after my catheter procedure.

Patient has an anticipated difficult intubation based upon airway exam and/or history of difficult intubation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Intubation with a novel ultrasound-detectable endotracheal tube (USD-ETT) and assessment of tube placement using ultrasound and fluoroscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intubation, including assessment of ventilation and oxygenation

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound-detectable Endotracheal Tube

Trial Overview

The study tests a new type of breathing tube that can be seen on ultrasound to check if it's placed correctly. The goal is to improve accuracy in positioning the tube either in depth or distinguishing between trachea and esophagus placement.

How Is the Trial Designed?

Group I: Ultrasound detectable cuffed endotracheal tube (USD-ETT) Experimental Treatment 1 Intervention

Intubation with a novel ultrasound-detectable endotracheal tube

Who Is Running the Clinical Trial?

John R. Charpie

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Point-of-care ultrasound is increasingly being used in pediatrics for various airway assessments, including endotracheal tube sizing and placement, which can enhance safety and efficacy in critical care settings.

This scoping review provides essential technical guidance and ultrasound images to help healthcare professionals effectively utilize ultrasound for airway management in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Ultrasonographic Techniques in the Evaluation of the Pediatric Airway. Burton, L., Bhargava, V.[2023]

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]

The novel ultrasound method for assessing endotracheal tube (ETT) position in neonates showed excellent accuracy, identifying 100% of correctly positioned ETTs when compared to chest radiography (CXR), with a strong agreement (kappa=0.822).

The ultrasound method demonstrated high specificity (100%) and positive predictive value (100%), indicating it is a reliable tool for confirming ETT placement in neonates without any adverse events during the scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound assessment of endotracheal tube depth in neonates: a prospective feasibility study. Levkovitz, O., Schujovitzky, D., Stackievicz, R., et al.[2023]

In a study involving 50 children aged 1-10 years undergoing general anesthesia, ultrasonography (USG) successfully predicted the appropriate size of cuffed endotracheal tubes (ETTs) with an 86% first attempt success rate.

The measurements of the subglottic airway diameter using USG proved to be a reliable method for estimating the correct ETT size, reducing the need for tube replacements during intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonographic Measurement of Subglottic Diameter for Paediatric Cuffed Endotracheal Tube Size Selection: Feasibility Report. Altun, D., Sungur, MO., Ali, A., et al.[2022]

Ultrasonography (US) has been shown to be a useful tool for predicting difficult intubation, with specific indicators like 'skin thickness at the epiglottis and hyoid levels' correlating with challenging airway assessments.

The review analyzed 26 studies and identified 45 different US indicators, highlighting the need for further external validation of these indicators to confirm their reliability in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasonography indicators for predicting difficult intubation: a systematic review and meta-analysis. Sotoodehnia, M., Rafiemanesh, H., Mirfazaelian, H., et al.[2021]

In a study of 100 emergency department patients, the ultrasound technique using the suprasternal notch (SSN) to the left of the trachea with pressure provided the highest rate of adequate airway visualization at 93%.

The findings suggest that applying pressure while scanning the SSN improves visualization of airway anatomy, which is crucial for confirming endotracheal tube placement during intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of techniques for visualisation of the airway anatomy for ultrasound-assisted intubation: A prospective study of emergency department patients. Romano, MJ., Lee, JS., Chenkin, J.[2019]

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25711517/

Ultrasonography for confirmation of endotracheal tube ...

Current evidence supports that ultrasonography has high diagnostic value for identifying esophageal intubation.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0300957215000805

Ultrasonography for confirmation of endotracheal tube ...

Current evidence supports that ultrasonography has high diagnostic value for identifying esophageal intubation.

3.

annemergmed.com

annemergmed.com/article/S0196-0644(18)30555-9/fulltext

Ultrasonography for the Confirmation of Endotracheal Tube ...

Ultrasonography can be a valuable adjunct for endotracheal tube placement confirmation, especially during cardiac arrest or when quantitative ...

4.

ceemjournal.org

ceemjournal.org/m/journal/view.php?doi=10.15441/ceem.23.094

Point-of-care ultrasound for airway management ...

Ultrasound can be used to assess for a difficult airway prior to intubation, allowing time for appropriate preparation and secondary plans for airway ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10177245/

Point-of-Care Ultrasound in Airway Evaluation and Management

Ultrasound can be used to assess the airway prior to intubation or procedural sedation, helping identify patients who may have an otherwise unanticipated ...

6.

journals.lww.com

journals.lww.com/ccejournal/fulltext/2020/09000/protocolized_tracheal_and_thoracic_ultrasound_for.19.aspx

Protocolized tracheal and thoracic ultrasound for confirmation

A protocolized, systematic approach using tracheal and thoracic ultrasonography can be used to confirm endotracheal intubation, detect main stem intubations, ...

7.

mdpi.com

mdpi.com/2227-9032/13/13/1502

Airway Ultrasound: A Narrative Review of Present Use and ...

Results: Ultrasound has demonstrated utility in pre-intubation risk stratification using quantitative measures such as skin-to-epiglottis distance (>2.75 cm) ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2256208715000334

Airway management using ultrasound

This review discusses the role of ultrasound as an additional complementary tool in the management of the airway in different situations, including the ...