Evaluation of Modified Bite-Block for Invasive Imaging Procedures

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

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.

Study Overview

• Status: Completed
• Conditions: Bite Block
• Intervention / Treatment: Device: bite block

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Modified Bite Block; Patients undergoing transesophageal echocardiogram under sedation or general anesthesia during which a modified bite block is used	Device: bite block; Physicians performing transesophageal echocardiogram in patients under sedation or general anesthesia will use either standard or modified bite block.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: bite block, transesophageal echocardiography
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Wounds and Injuries; Poisoning; Bites and Stings
• Other Study ID Numbers: STUDY00004883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No