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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Hypoxia, Hypercapnia

Intervention / Treatment
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* Device: TwinGuard
* Device: Standard endoscopic bite block
* Device: Standard nasal cannula
* Device: CO2 sample line


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention of hypoxia, prevention of hypercapnia