Evaluation of Modified Bite-Block for Invasive Imaging Procedures

Bite Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04236297
• Other study ID #: STUDY00004883
• Status: Completed
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bite Block
• Bites and Stings

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dislodgment	Number of participants with bite block dislodgment which will be determined by provider questionnaire	Within 24 hours
Secondary	Provider satisfaction	Number of providers that would use standard or redesigned bite block again	Within 24 hours