Evaluation of Modified Bite-Block for Invasive Imaging Procedures

NCT ID: NCT04236297

Last Updated: 2022-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-22
• Study Completion Date: 2020-12-31

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

Conditions

Bite Block

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Modified Bite Block

Patients undergoing transesophageal echocardiogram under sedation or general anesthesia during which a modified bite block is used

Group Type: OTHER

bite block

Intervention Type: DEVICE

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

Interventions

bite block

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Srdjan Jelacic

Assistant Professor, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Srdjan Jelacic, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

STUDY00004883

Identifier Type: -

Identifier Source: org_study_id