Ultrasound-detectable Endotracheal Tube: a Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2027-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cardiac Catheterization Endotracheal Tube

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

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."

Study Groups

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Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Intubation with a novel ultrasound-detectable endotracheal tube

Group Type EXPERIMENTAL

Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Intervention Type DEVICE

Intubation with a novel ultrasound-detectable endotracheal tube

Interventions

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Ultrasound detectable cuffed endotracheal tube (USD-ETT)

Intubation with a novel ultrasound-detectable endotracheal tube

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

42 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No