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.

Study Overview

• Status: Completed
• Conditions: Airway Obstruction
• Intervention / Treatment: Device: Mandibular advancement bite block

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Department of Anesthesiology, Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ASA class I or II patients admitted for routine upper gastrointestinal endoscopy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard; Standard bite block
Mandibular advancement 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	up to 30 minutes

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Wei-Nung Teng, MD, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Estimate): November 16, 2016
• Last Update Submitted That Met QC Criteria: November 10, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Gastrointestinal endoscopy; Airway management; Moderate sedation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: 2016-04-003C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED