Clinical trial NCT04236297: Evaluation of Modified Bite-Block for Invasive Imaging Procedures
Official title: Evaluation of Modified Bite-Block vs Standard Bite Block for Invasive Imaging Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bite Block
Keywords: bite block, transesophageal echocardiography
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Oral injury
timeFrame: Within 24 hours
Secondary outcomes:
measure: Dislodgment
timeFrame: Within 24 hours
measure: Provider satisfaction
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Srdjan Jelacic, MD
role: PRINCIPAL_INVESTIGATOR
References: