Mandibular Advancement Bite Block Efficacy Observational Study
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|ClinicalTrials.gov Identifier: NCT02964299|
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : November 16, 2016
|Condition or disease||Intervention/treatment|
|Airway Obstruction||Device: Mandibular advancement bite block|
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.
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Observational Model:||Case Control|
|Official Title:||Mandibular Advancement Bite Block Efficacy Observational Study|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Standard bite block
Mandibular advancement bite block
Mandibular advancement by 3 mm, 6 mm or 9 mm from neutral position
Device: Mandibular advancement bite block
Mandibular advancement bite block that provides mandibular advancement by 3 mm, 6 mm, or 9 mm from neutral position
- Area under curve of 95% oxygen desaturation [ Time Frame: up to 30 minutes ]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.
- number of rescue interventions: chin lift, jaw thrust, insertion of nasal airway or mask-bag ventilation [ Time Frame: up to 30 minutes ]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.
- Adverse events: partial or complete airway obstruction, or apnea [ Time Frame: up to 30 minutes ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964299
|Department of Anesthesiology, Taipei Veterans General Hospital|
|Taipei, Taiwan, 112|
|Principal Investigator:||Wei-Nung Teng, MD||Taipei Veterans General Hospital, Taiwan|