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

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.

Completed

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Key information

Conditions

Hypoxia Hypercapnia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TwinGuard

Device

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.

Standard endoscopic bite block

Device

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

Standard nasal cannula

Device

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.

CO2 sample line

Device

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

Sponsors and collaborators

Lead sponsor

Trawax Pty Limited

Other

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Feb 21, 2008
Registry last updated: Feb 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed