Mandibular Advancement Bite Block Efficacy Observational Study

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of mandibular advancement bite block to standard bite block for prevention of hypoxemia, intervention events and adverse effects during endoscopic examinations.

Detailed Description
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During endoscopic examinations, especially upper gastrointestinal, bile duct, or bronchoscopic examinations, the endoscope need to be placed through the mouth. A bite block is used to protect vulnerable endoscope and protect patient's teeth. During sedative endoscopic exams, respiratory depression, apnea or upper airway obstruction will occur under the influence of the sedative medications. Serious adverse events may occur such as hypoxemia. A nasal airway, Larson's maneuver, jaw thrust or chin lift may be needed to open airways. Mandibular advancement devices has been widely used in treating obstructive sleep apnea. A modified bite block that provides mandibular advancement could provide entry inlet of endoscope as well as provide mandibular advancement to provide patent airway during sedative endoscopy. In this study, we group the patients into test group using mandibular advancement bite block and a control group using standard bite block. After anesthetic induction, gastric endoscopy was performed. Degree of upper airway obstruction will be evaluated and recorded. Differences between the two groups will be evaluated.

Official Title
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Mandibular Advancement Bite Block Efficacy Observational Study

Conditions
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Airway Obstruction

Intervention / Treatment
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* Device: Mandibular advancement bite block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist class I or II Patients undergoing routine upper gastrointestinal endoscopy under sedation Exclusion Criteria: Baseline oxygen saturation < 90% Known difficult airway Oral or facial surgery history BMI > 35 patients with gastroparesis or gastrointestinal bleeding anticipated exam time > 30 minutes

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard<br>Standard bite block | |
| Mandibular advancement bite block<br>Mandibular advancement by 3 mm, 6 mm or 9 mm from neutral position | Device: Mandibular advancement bite block<br>* Mandibular advancement bite block that provides mandibular advancement by 3 mm, 6 mm, or 9 mm from neutral position<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve of 95% oxygen desaturation | From start of sedation drug administration to end of endoscopic examination with the endoscope withdrawal from patient's mouth, peripheral oxygen saturation recorded. Area under curve of 95% oxygen desaturation is calculated by (95-saturation) x time. | up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of rescue interventions: chin lift, jaw thrust, insertion of nasal airway or mask-bag ventilation | From start of sedation drug administration to end of endoscopic examination with the endoscope withdrawal from patient's mouth, number of events such as chin lift, jaw thrust, insertion of nasal airway, or mask-bag ventilation recorded. | up to 30 minutes | 
| Adverse events: partial or complete airway obstruction, or apnea | From start of sedation drug administration to end of endoscopic examination with the endoscope withdrawal from patient's mouth, number of events such as snoring, stridor, apnea, airway obstruction or loss of end tidal carbon dioxide waveform recorded. | up to 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal endoscopy, Moderate sedation, Airway management