NCT02964299

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

October 26, 2016

Last Update Submit

November 10, 2016

Conditions

Airway Obstruction

Keywords

Gastrointestinal endoscopyModerate sedationAirway management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • number of rescue interventions: chin lift, jaw thrust, insertion of nasal airway or mask-bag ventilation

    up to 30 minutes

  • Adverse events: partial or complete airway obstruction, or apnea

    up to 30 minutes

Study Arms (2)

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

Interventions

Mandibular advancement bite blockDEVICE

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

Mandibular advancement bite block

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • American Society of Anesthesiologist class I or II
  • Patients undergoing routine upper gastrointestinal endoscopy under sedation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Taipei Veterans General Hospital

Taipei, Taiwan, 112, Taiwan

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Wei-Nung Teng, MD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2016

First Posted

November 16, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

TW(1)