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

Phase 2

Completed

• Conditions: Hypoxia; Hypercapnia

• Registration Number: NCT00619606
• Lead Sponsor: Trawax Pty Limited

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)

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2008-01-31
• Status Verified: 2008-02
• Study First Submitted QC: 2008-02-20
• Last Update Submitted: 2008-02-20
• Study First Posted: 2008-02-21
• Last Update Posted: 2008-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL