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

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 Ultrasound-detectable Endotracheal Tube for airway management?

Research shows that using ultrasound can accurately confirm the correct placement of endotracheal tubes (ETT) in patients, which is crucial for effective airway management. This suggests that an ultrasound-detectable ETT could improve the accuracy and safety of tube placement. ^{1 2 3 4 5}

What makes the Ultrasound-detectable Endotracheal Tube (USD-ETT) treatment unique for airway management?

The Ultrasound-detectable Endotracheal Tube (USD-ETT) is unique because it allows for real-time visualization and confirmation of tube placement using ultrasound, which can improve accuracy and safety during intubation compared to traditional methods that rely on physical examination or X-rays. ^{1 2 4 6 7}

What is the purpose of this trial?

The researchers are studying whether special features make it easier to see if the breathing tube is in the correct place. It is hoped that the investigational device will enable more accurate placement (depth and trachea vs. esophagus).

Research Team

John Charpie, MD, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. France 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. [2019]

2. India pubmed.ncbi.nlm.nih.gov

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

3. Spain pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Ultrasound assessment of endotracheal tube depth in neonates: a prospective feasibility study. [2023]

5. Turkey pubmed.ncbi.nlm.nih.gov

Ultrasonographic Measurement of Subglottic Diameter for Paediatric Cuffed Endotracheal Tube Size Selection: Feasibility Report. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Ultrasonography indicators for predicting difficult intubation: a systematic review and meta-analysis. [2021]

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

A Scoping Review of Ultrasonographic Techniques in the Evaluation of the Pediatric Airway. [2023]