NCT05941013

Ultrasound-detectable Endotracheal Tube: a Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: John R. Charpie · Academic / Other
• Sex: All
• Age: 6 Months – 42 Months
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Cardiac Catheterization
• Endotracheal Tube

Interventions

Type	Name	Description
DEVICE	Ultrasound detectable cuffed endotracheal tube (USD-ETT)	Intubation with a novel ultrasound-detectable endotracheal tube

Timeline

• Start date: 2023-11-15
• Primary completion: 2027-03-01
• Completion: 2027-04-01
• First posted: 2023-07-12
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study