Skip to main content
OpenTrials
Completed

NCT Number: NCT04236297

Evaluation of Modified 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bite Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bite block

Device

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

Primary outcomes

  1. Oral injury

    Time frame: Within 24 hours

    Number of participants with oral injury (dental injury, lacerations/bruises on gums and lips) which will be determined by examination

Secondary outcomes

  1. Dislodgment

    Time frame: Within 24 hours

    Number of participants with bite block dislodgment which will be determined by provider questionnaire

  2. Provider satisfaction

    Time frame: Within 24 hours

    Number of providers that would use standard or redesigned bite block again

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 22, 2020
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.