Clinical Trial: Mandibular Advancement Bite Block Efficacy Observational Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Mandibular Advancement Bite Block Efficacy Observational Study

Brief Summary: 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 Summary:

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.


Sponsor: Taipei Veterans General Hospital, Taiwan

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Taipei Veterans General Hospital, Taiwan

Dates:
Date Received: October 26, 2016
Date Started: July 2016
Date Completion:
Last Updated: November 10, 2016
Last Verified: November 2016