An observational study in Airway Obstruction, sponsored by Taipei Veterans General Hospital, Taiwan. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-11-16.
Sponsored by Taipei Veterans General Hospital, Taiwan · Observational
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.
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.
154 studies on the registry are indexed under Airway Obstruction; 30 are open to participants now.
This study's enrollment of 120 is close to the median of 120 across 59 observational studies indexed under Airway Obstruction.
Browse Airway Obstruction studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ASA class I or II patients admitted for routine upper gastrointestinal endoscopy
Exclusion Criteria:
Standard 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
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.
Time frame: up to 30 minutes
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.
Time frame: 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.
Time frame: up to 30 minutes
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Taipei Veterans General Hospital, Taiwan