Evaluation of Modified Bite-Block for Invasive Imaging Procedures

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Bite Block

Intervention / Treatment
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* Device: bite block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Modified Bite Block<br>Patients undergoing transesophageal echocardiogram under sedation or general anesthesia during which a modified bite block is used | Device: bite block<br>* Physicians performing transesophageal echocardiogram in patients under sedation or general anesthesia will use either standard or modified bite block.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dislodgment | Number of participants with bite block dislodgment which will be determined by provider questionnaire | Within 24 hours | 
| Provider satisfaction | Number of providers that would use standard or redesigned bite block again | Within 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bite block, transesophageal echocardiography