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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
Oxygenating Bite Block will be used instead of the standard bite block.
Cedars Sinai Medical Center
Los Angeles, California, United States
OBB Device Feasibility
SPO2 -Subject desaturation
Time frame: During the upper endoscopy procedure
Tolerability of the Oxygenating Bite Block - Patients
Questionnaire Satisfaction with the level of sedation and OBB tolerability?
Time frame: After the endoscopy, up to 5 minutes
Tolerability of the Oxygenating Bite Block - Anesthesiologist
Questionnaire Was the OBB easy to use, protected the subject's oral cavity, and oxygenated effectively?
Time frame: After the endoscopy, up to 5 minutes
Tolerability of the Oxygenating Bite Block - Endoscopist
Questionnaire - Endoscopist Did your patient tolerate the OBB well, and will you use it again?
Time frame: After the endoscopy, up to 5 minutes
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