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

This study has been completed.
Sponsor:
Information provided by:
Trawax Pty Limited
ClinicalTrials.gov Identifier:
NCT00619606
First received: January 31, 2008
Last updated: February 20, 2008
Last verified: February 2008

January 31, 2008
February 20, 2008
November 2006
March 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00619606 on ClinicalTrials.gov Archive Site
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To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure
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

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.

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)

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Hypoxia
  • Hypercapnia
  • Device: TwinGuard
    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.
  • Device: Standard endoscopic bite block
    Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth
  • Device: Standard nasal cannula
    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.
  • Device: CO2 sample line
    Samples expired air from a patients nose. Tubing is connected to a capnograph.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00619606
CDD05/C05, TGA CTN 089/2006
Yes
Julie Nunn, Trawax Pty Ltd
Trawax Pty Limited
Not Provided
Principal Investigator: Thomas J Borody Centre for Digestive Diseases, Sydney
Trawax Pty Limited
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP