HypoxiaPhase 2NCT00619606
To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure
A Phase 2 study testing TwinGuard, Standard endoscopic bite block and Standard nasal cannula in people with Hypoxia and Hypercapnia, run by Trawax Pty Limited.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Hypercapnia
- What is being tested?
- TwinGuard, Standard endoscopic bite block and Standard nasal cannula
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients suffering from cardio respiratory disease, moderate to severe asthma, lung and heart disease
- Patients who have a history of drug or alcohol abuse
About this study
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
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.
Read the 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
- Being tested
- TwinGuard, Standard endoscopic bite block, Standard nasal cannula, CO2 sample line
- Keywords
- prevention of hypoxia, prevention of hypercapnia
- Medical subject headings
- Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TwinGuardDevice
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 blockDevice
Placed in the mouth during gastroscopy to protect the endoscope and the patient's teeth
Standard nasal cannulaDevice
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 lineDevice
Samples expired air from a patients nose. Tubing is connected to a capnograph.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startNov 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trawax Pty Limited
- Sponsor type
- University, hospital or other
- Investigators
- Thomas J Borody, Principal investigator, Centre for Digestive Diseases, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619606
- Sponsor's protocol ID
- CDD05/C05
- Other IDs
- TGA CTN 089/2006
- Status last verified
- Feb 2008
- First submitted
- 31 Jan 2008
- Last updated
- 21 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00619606
- Acronym / sponsor ID
- CDD05/C05
- Conditions
- Hypoxia, Hypercapnia
- Keywords
- prevention of hypoxia, prevention of hypercapnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Trawax Pty LimitedUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 21 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients suffering from cardio respiratory disease, moderate to severe asthma, lung and heart disease
- Patients who have a history of drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TwinGuardA 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 blockPlaced in the mouth during gastroscopy to protect the endoscope and the patient's teeth | Device | – |
| Standard nasal cannulaDelivers 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 lineSamples expired air from a patients nose. Tubing is connected to a capnograph. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Borody principal investigator
Centre for Digestive Diseases, Sydney
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TwinGuard, Standard endoscopic bite block and Standard nasal cannula in people with Hypoxia and Hypercapnia, run by Trawax Pty Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2008.