Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block (OBB)

Cedars-Sinai Medical Center

Status: Completed

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

Treatments: Device: Oxygenating Bite Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07086378

STUDY00003021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Oxygenating Bite Block (OBB)

Experimental group

Description:

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.

Treatment:

Device: Oxygenating Bite Block