Evaluating the Efficiency and Tolerability of the Oxygenating Bite Block

NCT07086378 | Completed Results FDA Device

• 1 other identifier: STUDY00003021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

airway management; Upper endoscopy

Outcome Measures

Primary Outcomes (1)

• OBB Device Feasibility

  SPO2 -Subject desaturation

  During the upper endoscopy procedure

Secondary Outcomes (3)

• 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

Study Arms (1)

Oxygenating Bite Block (OBB)

EXPERIMENTAL

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.

Device: Oxygenating Bite Block

Interventions

Oxygenating Bite Block DEVICE

Oxygenating Bite Block will be used instead of the standard bite block.

Oxygenating Bite Block (OBB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (2)

• de Paulo GA, Martins FP, Macedo EP, Goncalves ME, Mourao CA, Ferrari AP. Sedation in gastrointestinal endoscopy: a prospective study comparing nonanesthesiologist-administered propofol and monitored anesthesia care. Endosc Int Open. 2015 Feb;3(1):E7-E13. doi: 10.1055/s-0034-1377835. Epub 2015 Jan 16.

  PMID: 26134777 BACKGROUND

• Qadeer MA, Rocio Lopez A, Dumot JA, Vargo JJ. Risk factors for hypoxemia during ambulatory gastrointestinal endoscopy in ASA I-II patients. Dig Dis Sci. 2009 May;54(5):1035-40. doi: 10.1007/s10620-008-0452-2. Epub 2008 Nov 12.

  PMID: 19003534 BACKGROUND

Results Point of Contact

• Title: Dr. Robert Wong
• Organization: Cedars Sinai Medical Center

Robert.Wong@cshs.org

3104231682

Study Officials

• Robert Wong, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pilot study (ten subjects)

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: July 25, 2025
• Study Start: July 28, 2025
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)