To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure
Primary Purpose
Hypoxia, Hypercapnia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TwinGuard
Standard endoscopic bite block
Standard nasal cannula
CO2 sample line
Sponsored by
About this trial
This is an interventional supportive care trial for Hypoxia focused on measuring prevention of hypoxia, prevention of hypercapnia
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00619606
Brief Title
To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Trawax Pty Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, Hypercapnia
Keywords
prevention of hypoxia, prevention of hypercapnia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
TwinGuard
Intervention Description
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
Intervention Name(s)
Standard endoscopic bite block
Intervention Description
Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth
Intervention Type
Device
Intervention Name(s)
Standard nasal cannula
Intervention Description
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
Intervention Name(s)
CO2 sample line
Intervention Description
Samples expired air from a patients nose. Tubing is connected to a capnograph.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Borody
Organizational Affiliation
Centre for Digestive Diseases, Sydney
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure
We'll reach out to this number within 24 hrs