Improve Oxygenation and Capnographic Detection During Sedative EGD

July 6, 2017 updated by: Taipei Veterans General Hospital, Taiwan

Comparison of Techniques to Improve Oxygenation and Capnographic Detection During Sedative Gastrointestinal Endoscopy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Olympus standard bite block
Standard of care using standard bite block and nasal cannula
Device: Olympus standard bite block
Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and nasal cannula with oxygen 5L/min
Other Names:
  • A
Experimental: YX Mandibular advancement bite block
Mandibular advancement bite block group
Device: YX mandibular advancement bite block
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
Other Names:
  • B
Experimental: Optiflow High flow nasal cannula
High flow nasal cannula group
Device: Optiflow High flow nasal cannula
Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and high flow nasal cannula
Other Names:
  • C

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area under the curve of 95% oxygen desaturation (AUCdesat)
Time Frame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
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
From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of rescue interventions
Time Frame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
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.
From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Number of apnea episodes
Time Frame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
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.
From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Number of partial airway obstruction episodes
Time Frame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Number of partial airway obstruction episodes, which are number of times grunting or snoring with positive ETCO2 measurement greater than 30 secs occurs.
From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
Number of total airway obstruction episodes
Time Frame: From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour
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.
From time of first sedative medication given until the time of discharge from recovery room, assessed up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Veterans General Hospital, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wei-Nung Teng, MD, Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-03-003B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Apnea, Obstructive

Clinical Trials on Olympus standard bite block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings