Mandibular Advancement Bite Block Efficacy Observational Study

Airway Obstruction Clinical Trial

Official title:

Mandibular Advancement Bite Block Efficacy Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964299
• Other study ID #: 2016-04-003C
• Status: Completed
• Phase: N/A
• First received: October 26, 2016
• Last updated: November 10, 2016
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No