RECRUITING

Ultrasound-detectable Endotracheal Tube: a Feasibility Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Ultrasound-detectable Endotracheal Tube: a Feasibility Study

Quick Facts

Study Start:2023-11-15
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05941013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 42 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation.
  1. * Patient has a known airway abnormality, including tracheal stenosis, previous tracheal stenosis, or tracheobronchomalacia.
  2. * Patient has a tracheostomy.
  3. * Patient is ventilator-dependent.
  4. * Patient has an anticipated difficult intubation based upon airway exam and/or history of difficult intubation.
  5. * Patient is unlikely (in opinion of anesthesia team) or is unable to be intubated with 3.5 mm, 4.0 mm, or 4.5 mm Inner Diameter USD-ETT due to the size of the patient or their airway.
  6. * Patient is already intubated prior to the scheduled procedure.
  7. * It is anticipated that the patient will not be extubated after the catheterization procedure.
  8. * Concurrent enrollment in another clinical trial with an intervention during the cardiac catheterization procedure or 30 days afterwards.
  9. * Allergy to plastic/materials in USD-ETT

Contacts and Locations

Study Contact

Cynthia Smith, RN
CONTACT
734-615-0590
csmithw@med.umich.edu
Andrea Les, PhD
CONTACT
734-998-5585
asles@med.umich.edu

Principal Investigator

John Charpie, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: John R. Charpie

  • John Charpie, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-15
Study Completion Date2025-03

Study Record Updates

Study Start Date2023-11-15
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • Ultrasound
  • Intubation

Additional Relevant MeSH Terms

  • Cardiac Catheterization
  • Endotracheal Tube