Evaluation of Modified Bite-Block for Invasive Imaging Procedures

Not Applicable

Completed

• Conditions: Bite Block
• Interventions: Device: bite block

• Registration Number: NCT04236297
• Lead Sponsor: University of Washington

Brief 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

Study Timeline

• Study Start: 2019-08-22
• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-16
• Study First Posted: 2020-01-22
• Primary Completion: 2020-08-30
• Study Completion: 2020-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 years of age or older
• Undergoing stand-alone transesophageal echocardiography exam under sedation or general anesthesia
• Undergoing procedure that requires transesophageal echocardiography exam during the procedure under general anesthesia
• Cardiology and cardiac anesthesiology echocardiographers performing transesophageal echocardiography exam who wish to participate

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Exclusion Criteria

• Less than 18 years of age
• Any procedure that does not require transesophageal echocardiography exam during the procedure

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified Bite Block	bite block	Patients undergoing transesophageal echocardiogram under sedation or general anesthesia during which a modified bite block is used

Primary Outcome Measures

Name	Time	Method
Oral injury	Within 24 hours	Number of participants with oral injury (dental injury, lacerations/bruises on gums and lips) which will be determined by examination

Secondary Outcome Measures

Name	Time	Method
Provider satisfaction	Within 24 hours	Number of providers that would use standard or redesigned bite block again
Dislodgment	Within 24 hours	Number of participants with bite block dislodgment which will be determined by provider questionnaire

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States