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

NCT ID: NCT00619606

Last Updated: 2008-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2007-03-31

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)

Conditions

Hypoxia; Hypercapnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Standard endoscopic bite block

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

Intervention Type: 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.

Intervention Type: DEVICE

CO2 sample line

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Trawax Pty Limited

OTHER

Sponsor Role: lead

Responsible Party

Trawax Pty Ltd

Principal Investigators

Thomas J Borody

Role: PRINCIPAL_INVESTIGATOR

Centre for Digestive Diseases, Sydney

Other Identifiers

TGA CTN 089/2006

Identifier Type: -

Identifier Source: secondary_id

CDD05/C05

Identifier Type: -

Identifier Source: org_study_id