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Procedure

USD-ETT for Airway Management

N/A

Recruiting

Led By John Charpie, MD, PhD

Research Sponsored by John R. Charpie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation

Awards & highlights

Study Summary

This trial studies a new device to help doctors place a breathing tube accurately and safely.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort during intubation, possible allergic reactions to the tube material (if not previously known), and complications related to incorrect placement if the device does not perform as expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days post intubation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days post intubation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days post intubation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of the USD-ETTs visualized by ultrasound

Secondary outcome measures

Adverse events that could be related to the USD-ETT device

Kappa agreement between placement location of USD-ETT as assessed by ultrasound and fluoroscopy

Safely support ventilation and oxygenation of the patient during the procedure

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ultrasound detectable cuffed endotracheal tube (USD-ETT)Experimental Treatment1 Intervention

Intubation with a novel ultrasound-detectable endotracheal tube

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

John R. CharpieLead Sponsor

John Charpie, MD, PhDPrincipal InvestigatorUniversity of Michigan

Media Library

Ultrasound-detectable Endotracheal Tube (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05941013 — N/A

Cardiac Catheterization Research Study Groups: Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Cardiac Catheterization Clinical Trial 2023: Ultrasound-detectable Endotracheal Tube Highlights & Side Effects. Trial Name: NCT05941013 — N/A

Ultrasound-detectable Endotracheal Tube (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05941013 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still active for this experiment?

"According to clinicaltrials.gov, this research effort is no longer recruiting subjects at the moment - having been first posted on July 1st 2023 and latest updated a week later. Alternatively, there are 7 other studies that have vacancies open for participants."

Answered by AI

Does this research project accept volunteers that are beyond the age of twenty?

"This medical study is exclusively recruiting patients between 6 and 42 months old. Additionally, there are 5 trials available for those aged 65 or above, as well as 2 specifically tailored to people below the age of 18."

Answered by AI

Is eligibility for this research study open to me?

"Candidates suitable for this medical trial must have had a cardiac catheterization and range between 6 months to 42 Months. Currently, the study is looking to recruit 20 individuals in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ultrasound-detectable Endotracheal Tube: a Feasibility Study

John R. Charpie 2023. "Ultrasound-detectable Endotracheal Tube: a Feasibility Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05941013.