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NCT Number: NCT05941013

Ultrasound-detectable Endotracheal Tube: a Feasibility Study

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).

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Key information

Age range

6 month–42 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The participant will have a breathing tube where the balloon (cuff) at the end of the tube has two special features: 1) The balloon will have a divot in it, rather than be round in shape, and 2) The balloon will be filled with saline (salt water), rather than air. The breathing tube is called an ultrasound detectable cuffed endotracheal tube (USD-ETT).

The USD-ETT has not been tested or used in humans previously.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Device

Intubation with a novel ultrasound-detectable endotracheal tube

Primary outcomes

  1. Proportion of the USD-ETTs visualized by ultrasound

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

    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.

Secondary outcomes

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

    Time frame: Up to 30 days post intubation

  2. Safely support ventilation and oxygenation of the patient during the procedure

    Time frame: Immediately following extubation

    Assessed by the question: "Were there any desaturation events, inability to property ventilate the patient or, blood gas abnormalities, that could be attributable to the ETT?" will be described

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

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

    Ultrasound location data compared to fluoroscopy location data using a weighted Kappa statistic

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Les, PhD

CONTACT

[email protected]

734-998-5585

Cynthia Smith, RN

CONTACT

[email protected]

734-615-0590

Sponsors and collaborators

Lead sponsor

John R. Charpie

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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