Evaluation of Modified Bite-Block for Invasive Imaging Procedures

University of Washington

Status

Completed

Conditions

Bite Block

Treatments

Device: bite block

Study type

Interventional

Funder types

Other

Identifiers

NCT04236297

STUDY00004883

Details and patient eligibility

About

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.

Full 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

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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