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Improve Oxygenation and Capnographic Detection During Sedative EGD

Primary Purpose

Upper Airway Obstruction, Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Olympus standard bite block
YX mandibular advancement bite block
Optiflow High flow nasal cannula
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Upper Airway Obstruction focused on measuring intravenous sedation, esophagogastroduodenalscopy, upper airway, mandibular advancement device, high flow nasal cannula

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients aged 20 to 80 years with ASA physical status I to II undergoing routine outpatient upper gastrointestinal endoscopy

Exclusion Criteria:

  • Baseline oxygen saturation < 90%
  • Known upper airway obstruction, difficult intubation history
  • Unstable or lost of upper and lower incisors
  • Known past oral or neck surgeries
  • Anticipate exam time > 30 mins

Sites / Locations

  • Department of Anesthesiology, Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Olympus standard bite block

YX Mandibular advancement bite block

Optiflow High flow nasal cannula

Arm Description

Standard of care using standard bite block and nasal cannula

Mandibular advancement bite block group

High flow nasal cannula group

Outcomes

Primary Outcome Measures

Area under the curve of 95% oxygen desaturation (AUCdesat)
AUCdesat is defined as the integrated area under oxygen saturation (SPO2) for a selected cut point per 30 seconds, which better reflects the duration and severity of hypoxemia than the lowest saturation

Secondary Outcome Measures

Number of rescue interventions
Number of rescue interventions counted if any of the following procedures are performed, such as sustained chin lift or jaw thrust, insertion of an oral or nasal airway or bag-mask ventilation.
Number of apnea episodes
Number of apnea episodes, which are number of times which the patient lack respiratory activity and loss of ETCO2 detection greater for 30 seconds occurs.
Number of partial airway obstruction episodes
Number of partial airway obstruction episodes, which are number of times grunting or snoring with positive ETCO2 measurement greater than 30 secs occurs.
Number of total airway obstruction episodes
Number of total airway obstruction episodes, which are number of times loss of ETCO2 detection while in presence of respiratory activity greater than 30 secs occurs.

Full Information

First Posted
April 18, 2017
Last Updated
July 6, 2017
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03138850
Brief Title
Improve Oxygenation and Capnographic Detection During Sedative EGD
Official Title
Comparison of Techniques to Improve Oxygenation and Capnographic Detection During Sedative Gastrointestinal Endoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
June 22, 2017 (Actual)
Study Completion Date
June 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the effect of mandibular advancement bite block and high flow nasal cannula to standard bite block for oxygenation, capnographic measurement, prevention of hypoxemia, intervention events and adverse effects during endoscopic examinations.
Detailed Description
During endoscopic examinations, especially during those performed via oral insertion of endoscopes, an oral bite is used to protect the examination instruments and patients. During sedated endoscopic examinations, the patients are under influence of anesthetics. Upper airway obstruction often occurred due to respiratory depression and airway collapse resulting in desaturation. Airway management with high percentage oxygen, jaw thrust, or insertion of nasal airways by trained anesthetic personnel is required during upper airway obstruction emergencies. Nasal airway is invasive and causes nasal bleeding, sinusitis and other problems. Jaw thrust and bag-mask ventilation requires training and is a burden to anesthetic personnel to perform. Oxygenation and capnography are important ventilatory monitors during sedative procedures. These are often influenced by open mouth breathing during upper gastrointestinal endoscopic examinations making oxygenation and capnographic measurements unreliable. In this study, we group the patients into A group using standard of care, B group using mandibular advancement oral bite and C group using high-flow nasal cannulas. After anesthetic induction, gastric endoscopy will be performed. Oxygenation, end-tidal carbon dioxide, and degree of upper airway obstruction will be evaluated and recorded. Differences between the groups will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Airway Obstruction, Apnea, Obstructive
Keywords
intravenous sedation, esophagogastroduodenalscopy, upper airway, mandibular advancement device, high flow nasal cannula

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olympus standard bite block
Arm Type
Experimental
Arm Description
Standard of care using standard bite block and nasal cannula
Arm Title
YX Mandibular advancement bite block
Arm Type
Experimental
Arm Description
Mandibular advancement bite block group
Arm Title
Optiflow High flow nasal cannula
Arm Type
Experimental
Arm Description
High flow nasal cannula group
Intervention Type
Device
Intervention Name(s)
Olympus standard bite block
Other Intervention Name(s)
A
Intervention Description
Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and nasal cannula with oxygen 5L/min
Intervention Type
Device
Intervention Name(s)
YX mandibular advancement bite block
Other Intervention Name(s)
B
Intervention Description
Intravenous sedative upper gastrointestinal endoscopy performed under mandibular advancement bite block for endoscopy (Yong Xu breathing mouth piece, Yong Xu) and oxygen connected to mouth piece 5L/min
Intervention Type
Device
Intervention Name(s)
Optiflow High flow nasal cannula
Other Intervention Name(s)
C
Intervention Description
Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and high flow nasal cannula
Primary Outcome Measure Information:
Title
Area under the curve of 95% oxygen desaturation (AUCdesat)
Description
AUCdesat is defined as the integrated area under oxygen saturation (SPO2) for a selected cut point per 30 seconds, which better reflects the duration and severity of hypoxemia than the lowest saturation
Time Frame
From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Secondary Outcome Measure Information:
Title
Number of rescue interventions
Description
Number of rescue interventions counted if any of the following procedures are performed, such as sustained chin lift or jaw thrust, insertion of an oral or nasal airway or bag-mask ventilation.
Time Frame
From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Title
Number of apnea episodes
Description
Number of apnea episodes, which are number of times which the patient lack respiratory activity and loss of ETCO2 detection greater for 30 seconds occurs.
Time Frame
From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Title
Number of partial airway obstruction episodes
Description
Number of partial airway obstruction episodes, which are number of times grunting or snoring with positive ETCO2 measurement greater than 30 secs occurs.
Time Frame
From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Title
Number of total airway obstruction episodes
Description
Number of total airway obstruction episodes, which are number of times loss of ETCO2 detection while in presence of respiratory activity greater than 30 secs occurs.
Time Frame
From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients aged 20 to 80 years with ASA physical status I to II undergoing routine outpatient upper gastrointestinal endoscopy Exclusion Criteria: Baseline oxygen saturation < 90% Known upper airway obstruction, difficult intubation history Unstable or lost of upper and lower incisors Known past oral or neck surgeries Anticipate exam time > 30 mins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Nung Teng, MD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Improve Oxygenation and Capnographic Detection During Sedative EGD

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