Mandibular Advancement Bite Block Efficacy Observational Study

Completed

• Conditions: Airway Obstruction
• Interventions: Device: Mandibular advancement bite block

• Registration Number: NCT02964299
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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 Description

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 Timeline

• Study Start: 2016-07
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Study First Submitted: 2016-10-26
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-10
• Last Update Submitted: 2016-11-10
• Study First Posted: 2016-11-16
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mandibular advancement bite block	Mandibular advancement bite block	Mandibular advancement by 3 mm, 6 mm or 9 mm from neutral position

Primary Outcome Measures

Name	Time	Method
Area under curve of 95% oxygen desaturation	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events: partial or complete airway obstruction, or apnea	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.
number of rescue interventions: chin lift, jaw thrust, insertion of nasal airway or mask-bag ventilation	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.

Trial Locations

Locations (1)

Department of Anesthesiology, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan