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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Bite Block | Other | Patients undergoing transesophageal echocardiogram under sedation or general anesthesia during which a modified bite block is used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bite block | Device | Physicians performing transesophageal echocardiogram in patients under sedation or general anesthesia will use either standard or modified bite block. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Srdjan Jelacic, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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| Within 24 hours |