NCT04236297

Evaluation of Modified Bite-Block for Invasive Imaging Procedures

Evaluation of Modified Bite-Block vs Standard Bite Block for Invasive Imaging Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography procedures in patients who are either sedated or under general anesthesia. These dental protector devices are class I devices which are exempt from the FDA 510(k) premarket notification requirements.

Detailed description

Bite block is a single-use medical device used to keep the mouth open during invasive imaging procedures and prevent the patient from biting the imaging probe. The purpose of this study is to compare a modified bite block with standard bite block during transesophageal echocardiography exam procedures in patients who are either sedated or under general anesthesia. The commercially available bite blocks are almost exclusively made of hard plastic that does not conform well to the patient's mouth with additional protrusions used to secure the bite block in place that have the potential to cause patient injury. Hard plastic is used to prevent patient from biting down on the imaging probe while side protrusions are used to strap the bite block down to prevent dislodgment. Modified bite block is made of softer material with improved mouth fit and no need for strapping the bite block to keep it in place. Softer material is more comfortable while the designs mimics mouth guard used in dentistry to protect patient's teeth and keep the bite block in place while sleeping. The specific aims of this project include: * assessment of patient comfort during invasive imaging procedure * assessment of provider satisfaction with the bite block * assessment of patient lip/gum/teeth injury after bite block use * assessment of imaging probe damage after procedure * assessment of bite block's ability to stay in place during procedure

Conditions

• Bite Block

Interventions

Type	Name	Description
DEVICE	bite block	Physicians performing transesophageal echocardiogram in patients under sedation or general anesthesia will use either standard or modified bite block.

Timeline

• Start date: 2019-08-22
• Primary completion: 2020-08-30
• Completion: 2020-12-31
• First posted: 2020-01-22
• Last updated: 2022-04-15

Locations

1 site across 1 country: United States