NCT00619606

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Trawax Pty Limited · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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)

Conditions

• Hypoxia
• Hypercapnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2008-02-21
• Last updated: 2008-02-21