Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- OBB Device Feasibility
研究概览
简要总结
This study will test an investigational bite block, which is a device placed inside the mouth to protect the teeth and used to keep the endoscope (a long, flexible tube that is placed down the throat and into the esophagus that contains a light and camera used to provide a visual of the area) in place. This Oxygenating bite block has been modified to allow the convenient use of an oral nasal cannula for administration of oxygen and sampling of end-tidal carbon dioxide (measurement of the amount of carbon dioxide exhaled at the end of a breath) during endoscopic procedures.
详细描述
This study will last one day and is completely voluntary.
The primary objective of this study is to evaluate the tolerability and efficacy of the device. The investigator will be testing how this device improves the flow of oxygen and provides safer sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Obese patients scheduled to undergo upper endoscopy,
- •Willingness and ability to sign an informed consent document,
- •ASA class I - III obese adults,
- •Subjects will be of diverse racial and ethnic backgrounds.
排除标准
- •Patients deemed to be at significant airway risk,
- •Under 18 years of age, since there is no justification to include them,
- •Missing or loose incisor or canine teeth
- •Temporomandibular joint disease
- •Maxillofacial abnormalities (deformities of the jaw, lips, and tongue)
- •Pregnant women, since there is no justification to include them,
- •Emergency surgeries,
- •Any other conditions that may interfere with the conduct of the study.
研究组 & 干预措施
Oxygenating Bite Block (OBB)
During the endoscopy procedure, the oxygenating bite block will be placed in the mouth instead of the standard and customary bite block.
After the endoscopy procedure, the participant will be asked to complete a short questionnaire to find out their satisfaction with the level of sedation during the procedure, the tolerability of the device, and any discomfort.
干预措施: Oxygenating Bite Block (Device)
结局指标
主要结局
OBB Device Feasibility
时间窗: During the upper endoscopy procedure
SPO2 -Subject desaturation
次要结局
- Tolerability of the Oxygenating Bite Block - Patients(After the endoscopy, up to 5 minutes)
- Tolerability of the Oxygenating Bite Block - Anesthesiologist(After the endoscopy, up to 5 minutes)
- Tolerability of the Oxygenating Bite Block - Patients(After the endoscopy, up to 5 minutes)
- Tolerability of the Oxygenating Bite Block - Anesthesiologist(After the endoscopy, up to 5 minutes)
- Tolerability of the Oxygenating Bite Block - Endoscopist(After the endoscopy, up to 5 minutes)
研究者
Robert Wong
Principal Investigator
Cedars-Sinai Medical Center