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To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure

Primary Purpose

Hypoxia, Hypercapnia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TwinGuard
Standard endoscopic bite block
Standard nasal cannula
CO2 sample line
Sponsored by
Trawax Pty Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypoxia focused on measuring prevention of hypoxia, prevention of hypercapnia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Provided written fully informed consent as per protocol
  • No clinical evidence of significant respiratory conditions
  • Fasted for 6 hours prior to enrolment as per standard clinical practice for panendoscopy

Exclusion Criteria:

  • Patients suffering from cardio respiratory disease, moderate to severe asthma, lung and heart disease
  • Patients who have a history of drug or alcohol abuse

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2008
    Last Updated
    February 20, 2008
    Sponsor
    Trawax Pty Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00619606
    Brief Title
    To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure
    Official Title
    A Randomised, Parallel, Open Label Study to Determine the Efficacy of a New Oral-Nasal Oxygenating Device (TwinGuard) Compared to Standard Bite Block Plus Nasal Cannulae
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2006 (undefined)
    Primary Completion Date
    March 2007 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Trawax Pty Limited

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A comparative study which compares the end-tidal carbon dioxide and oxygen saturation levels of patients during endoscopy which have used either the new oral-nasal oxygenating device (TwinGuard), or a standard bite block plus nasal cannulae using an equivalent flow rate of oxygen.
    Detailed Description
    Hypoxia is common during endoscopy. Following sedation induction, oxygen saturation falls moderately in most patients, whilst some drop to unacceptable levels. To monitor such changes endoscopic practices routinely use oximeters and capnography. TwinGuard is an all-in-one device which incorporates a bite block with the functionality of nasal cannula as well as monitoring expired air (carbon dioxide)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypoxia, Hypercapnia
    Keywords
    prevention of hypoxia, prevention of hypercapnia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    TwinGuard
    Intervention Description
    A system consisting of an endoscopic bite block that fits together with a nasal cannula. After gastroscopy, the bite block is discarded leaving the patient receiving oxygen in recovery.An optional carbon dioxide sampling device fits with the TwinGuard in endoscopy to monitor expired air.
    Intervention Type
    Device
    Intervention Name(s)
    Standard endoscopic bite block
    Intervention Description
    Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth
    Intervention Type
    Device
    Intervention Name(s)
    Standard nasal cannula
    Intervention Description
    Delivers oxygen to the nose. Tubing runs from the nose around the back of the ears and under the chin which then runs to an oxygen source.
    Intervention Type
    Device
    Intervention Name(s)
    CO2 sample line
    Intervention Description
    Samples expired air from a patients nose. Tubing is connected to a capnograph.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Provided written fully informed consent as per protocol No clinical evidence of significant respiratory conditions Fasted for 6 hours prior to enrolment as per standard clinical practice for panendoscopy Exclusion Criteria: Patients suffering from cardio respiratory disease, moderate to severe asthma, lung and heart disease Patients who have a history of drug or alcohol abuse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas J Borody
    Organizational Affiliation
    Centre for Digestive Diseases, Sydney
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure

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