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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygenating Bite Block | Device | Oxygenating Bite Block will be used instead of the standard bite block. |
|
| Measure | Description | Time Frame |
|---|---|---|
| OBB Device Feasibility | SPO2 -Subject desaturation | During the upper endoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of the Oxygenating Bite Block - Patients | Questionnaire Satisfaction with the level of sedation and OBB tolerability? | After the endoscopy, up to 5 minutes |
| Tolerability of the Oxygenating Bite Block - Anesthesiologist |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Wong, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26134777 | Background | 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. | |
| 19003534 | Background |
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It is a small sample, only 10 subjects, it is a pilot study
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxygenating Bite Block (OBB) | During the endoscopy procedure, the OBB was placed in the mouth rather than the standard BB. 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. OBB was used instead of the standard bite block. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxygenating Bite Block (OBB) | During the endoscopy procedure, the OBB was placed in the mouth rather than the standard BB. 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. OBB was used instead of the standard bite block. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | OBB Device Feasibility | SPO2 -Subject desaturation | SpO2 < 90% | Posted | Count of Participants | Participants | During the upper endoscopy procedure |
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1 day (day of the procedure)
Mortality was ZERO
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxygenating Bite Block (OBB) | During the endoscopy procedure, the OBB was placed in the mouth rather than the standard BB. 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. OBB was used instead of the standard bite block. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Wong | Cedars Sinai Medical Center | 3104231682 | Robert.Wong@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2025 | May 8, 2025 | Prot_SAP_000.pdf |
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Mar 4, 2025 | May 8, 2025 | Prot_ICF_001.pdf |
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Pilot study (ten subjects)
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Questionnaire Was the OBB easy to use, protected the subject's oral cavity, and oxygenated effectively?
| 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? | After the endoscopy, up to 5 minutes |
| 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. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Participants |
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| Secondary | Tolerability of the Oxygenating Bite Block - Patients | Questionnaire Satisfaction with the level of sedation and OBB tolerability? | All subjects (100%) expressed satisfaction with the level of sedation and OBB tolerability | Posted | Count of Participants | Participants | After the endoscopy, up to 5 minutes |
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| Secondary | Tolerability of the Oxygenating Bite Block - Anesthesiologist | Questionnaire Was the OBB easy to use, protected the subject's oral cavity, and oxygenated effectively? | Anesthesiologists expressed that the OBB was easy to use, protected the subject's oral cavity, and oxygenated effectively. | Posted | Count of Participants | Participants | After the endoscopy, up to 5 minutes |
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| Secondary | Tolerability of the Oxygenating Bite Block - Endoscopist | Questionnaire - Endoscopist Did your patient tolerate the OBB well, and will you use it again? | Endoscopists expressed that the OBB was well tolerated and will you use it again. | Posted | Count of Participants | Participants | After the endoscopy, up to 5 minutes |
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| 0 |
| 10 |
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| 10 |
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| 10 |
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