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Mandibular Advancement Bite Block Efficacy Observational Study

T

Taipei Veterans General Hospital

Status

Completed

Conditions

Airway Obstruction

Treatments

Device: Mandibular advancement bite block

Study type

Observational

Funder types

Other

Identifiers

NCT02964299
2016-04-003C

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Standard
Description:
Standard bite block
Mandibular advancement bite block
Description:
Mandibular advancement by 3 mm, 6 mm or 9 mm from neutral position
Treatment:
Device: Mandibular advancement bite block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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