To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure - Full Text View

Sponsored by:	Trawax Pty Limited
Information provided by:	Trawax Pty Limited
ClinicalTrials.gov Identifier:	NCT00619606

Purpose

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.

Condition	Intervention	Phase
Hypoxia Hypercapnia	Device: TwinGuard Device: Standard endoscopic bite block Device: Standard nasal cannula Device: CO2 sample line	Phase II

MedlinePlus related topics: Animal Bites Endoscopy

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Trawax Pty Limited:

Enrollment:	150
Study Start Date:	November 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth

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.

Samples expired air from a patients nose. Tubing is connected to a capnograph.

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)

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619606

Sponsors and Collaborators

Trawax Pty Limited

Investigators

Principal Investigator:

Thomas J Borody

Centre for Digestive Diseases, Sydney

More Information

Responsible Party:	Trawax Pty Ltd ( Julie Nunn )
Study ID Numbers:	CDD05/C05, TGA CTN 089/2006
Study First Received:	January 31, 2008
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00619606
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Trawax Pty Limited:

prevention of hypoxia
prevention of hypercapnia

Study placed in the following topic categories:

Signs and Symptoms
Hypercapnia
Signs and Symptoms, Respiratory
Bites and Stings
Anoxia

ClinicalTrials.gov processed this record on January 16, 2009