Ultrasound-detectable Endotracheal Tube: a Feasibility Study

• Sponsor: John R. Charpie (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05941013
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cardiac Catheterization; Endotracheal Tube	Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT)	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: 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."
• Primary Purpose: Device Feasibility
• Official Title: Ultrasound-detectable Endotracheal Tube: a Feasibility Study
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound detectable cuffed endotracheal tube (USD-ETT) Intubation with a novel ultrasound-detectable endotracheal tube	Device: Ultrasound detectable cuffed endotracheal tube (USD-ETT); Intubation with a novel ultrasound-detectable endotracheal tube

Outcome Measures

Primary Outcome Measures

1. Proportion of the USD-ETTs visualized by ultrasound [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 Outcome Measures

1. Adverse events that could be related to the USD-ETT device [Up to 30 days post intubation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 42 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• John R. Charpie

Investigators

• Principal Investigator: John Charpie, MD, PhD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John R. Charpie, Professor of Pediatric Cardiology, Professor of Pediatrics, University of Michigan
• ClinicalTrials.gov Identifier: NCT05941013
• Other Study ID Numbers: HUM00234901
• First Posted: Jul 12, 2023
• Last Update Posted: Jul 12, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by John R. Charpie, Professor of Pediatric Cardiology, Professor of Pediatrics, University of Michigan: Ultrasound; Intubation

Study Results

No Results Posted as of Jul 12, 2023