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

NCT00619606 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2008-02-21

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Trawax Pty Limited

    lead OTHER

Principal Investigators

  • Thomas J Borody · Centre for Digestive Diseases, Sydney

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-03-31
Completion
2007-03-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00619606 on ClinicalTrials.gov