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Mandibular Advancement Bite Block Efficacy Observational Study

NCT ID: NCT02964299

Last Updated: 2016-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-10-31

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.

Conditions

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Airway Obstruction

Keywords

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Gastrointestinal endoscopy Moderate sedation Airway management

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard

Standard bite block

No interventions assigned to this group

Mandibular advancement bite block

Mandibular advancement by 3 mm, 6 mm or 9 mm from neutral position

Mandibular advancement bite block

Intervention Type DEVICE

Mandibular advancement bite block that provides mandibular advancement by 3 mm, 6 mm, or 9 mm from neutral position

Interventions

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Mandibular advancement bite block

Mandibular advancement bite block that provides mandibular advancement by 3 mm, 6 mm, or 9 mm from neutral position

Intervention Type DEVICE

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei-Nung Teng, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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2016-04-003C

Identifier Type: -

Identifier Source: org_study_id