Quantitive And Qualitive Assessment Of The Oxygen Delivery And EtCO2 Sampling With The Smart Bite Block Mark III During An Upper Endoscopic Procedure Under Sedation

Study Overview
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Brief Summary
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The study hypothesis is that a modified smart bite block system can deliver up to 10 liters/minute of supplemental oxygen orally with the CO2 monitoring performance substantially equivalent to the currently marketed smart bite block that delivers oxygen up to 5 liters/minute

Official Title
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Quantitive And Qualitive Assessment Of The Oxygen Delivery And EtCO2 Sampling With The Smart Bite Block Mark III During An Upper Endoscopic Procedure Under Sedation

Conditions
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Ventilatory Status of Deeply Sedated ERCP Patients

Intervention / Treatment
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* Device: monitored using currently marketed smart biteblock o2
* Device: monitored using investigational smart biteblock


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For the Adults Bite Bloc:Adults >18 years old and able to understand and give consent per the Ethics committee requirements,or younger patients requiring an Adult size Bite Bloc in the opinion of the PI for whom the legal guardians consented for the participation of the trial. Patients consented or which their legal guardians consented for the participation of this trial. Clinical need to use a Bite Bloc to maintain an open mouth and protect the endoscope. Pediatric patients:patients with small mouth that the PI thinks require a Pediatric Bite Bloc (36 French),which their legal guardians consented for the participation of this trial. Exclusion Criteria: Patients who are pregnant. Patients who in the opinion of the investigator should not participate. For Pediatric Bite Bloc:patients who need an Adult Bite Bloc to the investigators opinion or above the age of 12. Patients receiving oral or intravenous anticoagulants other than Aspirin or Plavix.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ERCP patients monitored using currently marketed smart biteblock o2 | Device: monitored using currently marketed smart biteblock o2<br>* oral nasal CO2 monitoring and oxygen delivery<br>|
| Experimental: 2<br>ERCP patients monitored using experimental biteblock delivering up to 10 lit/min oxygen | Device: monitored using investigational smart biteblock<br>* monitored during ERCP procedure with nasal CO2 sampling and oral oxygen delivery at a flow rate up to 10 lit/min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EtCO2 measurement on the investigational device is equivalent to measurement on the control device |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EtCO2, supplemental oxygen delivery, ERCP