Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block

Not Applicable

Not yet recruiting

• Conditions: Endoscopy, Digestive System; Airway Anesthesia; Airway Control; Airway Management

• Registration Number: NCT07086378
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2025-05-29
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Study Start: 2025-07-28
• Primary Completion: 2025-11-28
• Study Completion: 2025-11-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
OBB Device Feasibility	During the upper endoscopy procedure	SPO2 and CO2 data will be observed

Secondary Outcome Measures

Name	Time	Method
Tolerability of the Oxygenating Bite Block - Patients	After the endoscopy, up to 5 minutes	Questionnaire; 1. Are you satisfied with the level of sedation? (yes/no) 2 Did you tolerate the Oxygenating Bite block? (yes/no) 3. Any discomfort. (yes or no)
Tolerability of the Oxygenating Bite Block - Anesthesiologist	After the endoscopy, up to 5 minutes	Questionnaire; 1. Was the OBB easy to use? Yes No; 2. Did the OBB protect the teeth adequately? Yes No; 3. Did the OBB oxygenated effectively? Yes No; 4. Do you think the OBB Oxygenated more effectively than the currently available alternatives for MAC? Yes No; 5. Did the OBB monitor ETCO2 effectively? Yes No; 6. If available, will you use the OBB again in the future? Yes No; 7. Did your patient desaturate? Yes No; 8. What is your professional opinion of the Oxygenating Bite Block?
Tolerability of the Oxygenating Bite Block - Endocscopist	After the endoscopy, up to 5 minutes	Questionnaire - Endoscopist; 1. Did your patient tolerate the OBB? Yes No; 2. If available, will you use the OBB again for your cases? Yes No; 3. Did the OBB interfere with your ability to perform endoscopy? Yes No; 4. What is your professional opinion of the Oxygenating Bite Block?

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States