Skip to main content
OpenTrials
Completed

NCT Number: NCT02964299

Mandibular Advancement Bite Block Efficacy Observational Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Airway Obstruction Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, Taiwan, 112

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular advancement bite block

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2016
Registry last updated
Nov 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.