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Mandibular Advancement Bite Block Efficacy Observational Study

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ClinicalTrials.gov Identifier: NCT02964299
Recruitment Status : Completed
First Posted : November 16, 2016
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief 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.

Condition or disease Intervention/treatment
Airway Obstruction 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.


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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mandibular Advancement Bite Block Efficacy Observational Study
Study Start Date : July 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ASA class I or II patients admitted for routine upper gastrointestinal endoscopy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964299


Locations
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Taiwan
Department of Anesthesiology, Taipei Veterans General Hospital
Taipei, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Wei-Nung Teng, MD Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02964299     History of Changes
Other Study ID Numbers: 2016-04-003C
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Taipei Veterans General Hospital, Taiwan:
Gastrointestinal endoscopy
Moderate sedation
Airway management
Additional relevant MeSH terms:
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Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases