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

Hypoxia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619606
• Other study ID #: CDD05/C05
• Secondary ID: TGA CTN 089/2006
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2008
• Last updated: February 20, 2008
• Start date: November 2006
• Est. completion date: March 2007

Study information

• Verified date: February 2008
• Source: Trawax Pty Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypercapnia
• Hypoxia

Intervention

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.
• Standard endoscopic bite block
Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth
• 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.
• CO2 sample line
Samples expired air from a patients nose. Tubing is connected to a capnograph.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Trawax Pty Limited