Evaluation of Modified Bite-Block vs Standard Bite Block for Invasive Imaging Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Oral injury
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Less than 18 years of age
- •Any procedure that does not require transesophageal echocardiography exam during the procedure
研究组 & 干预措施
Modified Bite Block
Patients undergoing transesophageal echocardiogram under sedation or general anesthesia during which a modified bite block is used
干预措施: bite block (Device)
结局指标
主要结局
Oral injury
时间窗: Within 24 hours
Number of participants with oral injury (dental injury, lacerations/bruises on gums and lips) which will be determined by examination
次要结局
- Provider satisfaction(Within 24 hours)
- Dislodgment(Within 24 hours)
研究者
Srdjan Jelacic
Assistant Professor, School of Medicine
University of Washington