NCT05941013

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Nov 2023Apr 2027

First Submitted

Initial submission to the registry

May 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

May 31, 2023

Last Update Submit

February 3, 2026

Conditions

Cardiac CatheterizationEndotracheal Tube

Keywords

UltrasoundIntubation

Outcome Measures

Primary Outcomes (1)

  • Proportion of the USD-ETTs visualized by ultrasound

    Reported as a 'yes' or 'no' - this outcome simply seeks to verify if the ultrasound can detect the ultrasound detectable cuffed endotracheal tube. The outcome measure assesses if the device is detectable as designed. It does not assess health related information.

    Within 5 minutes of placing the ultrasound probe at the suprasternal notch after intubation

Secondary Outcomes (3)

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

    Up to 30 days post intubation

  • Safely support ventilation and oxygenation of the patient during the procedure

    Immediately following extubation

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

    Approximately 5 minutes after of placing the ultrasound probe at the suprasternal notch after intubation

Study Arms (1)

Ultrasound detectable cuffed endotracheal tube (USD-ETT)

EXPERIMENTAL

Intubation with a novel ultrasound-detectable endotracheal tube

Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Interventions

Ultrasound detectable cuffed endotracheal tube (USD-ETT)DEVICE

Intubation with a novel ultrasound-detectable endotracheal tube

Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Eligibility Criteria

Age6 Months - 42 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Patient has a known airway abnormality, including tracheal stenosis, previous tracheal stenosis, or tracheobronchomalacia.
  • Patient has a tracheostomy.
  • Patient is ventilator-dependent.
  • Patient has an anticipated difficult intubation based upon airway exam and/or history of difficult intubation.
  • 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.
  • Patient is already intubated prior to the scheduled procedure.
  • It is anticipated that the patient will not be extubated after the catheterization procedure.
  • Concurrent enrollment in another clinical trial with an intervention during the cardiac catheterization procedure or 30 days afterwards.
  • Allergy to plastic/materials in USD-ETT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

  • John Charpie, MD, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Smith, RN

CONTACT

734-615-0590csmithw@med.umich.edu

Andrea Les, PhD

CONTACT

734-998-5585asles@med.umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The outcomes assessor is "blinded" for outcome measure 4. Specifically the protocol says, "After each case is completed, the fluoroscopic images and ultrasound images will be interpreted by independent study team members who are blinded to the results of the other test."
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Pediatric Cardiology, Professor of Pediatrics

Study Record Dates

First Submitted

May 31, 2023

First Posted

July 12, 2023

Study Start

November 15, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)