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
NCT ID: NCT00814424
Last Updated: 2008-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2009-01-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
ERCP patients monitored using currently marketed smart biteblock o2
monitored using currently marketed smart biteblock o2
oral nasal CO2 monitoring and oxygen delivery
2
ERCP patients monitored using experimental biteblock delivering up to 10 lit/min oxygen
monitored using investigational smart biteblock
monitored during ERCP procedure with nasal CO2 sampling and oral oxygen delivery at a flow rate up to 10 lit/min
Interventions
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monitored using currently marketed smart biteblock o2
oral nasal CO2 monitoring and oxygen delivery
monitored using investigational smart biteblock
monitored during ERCP procedure with nasal CO2 sampling and oral oxygen delivery at a flow rate up to 10 lit/min
Eligibility Criteria
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Inclusion Criteria
* 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 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.
ALL
No
Sponsors
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Oridion
INDUSTRY
Hadassah Medical Organization
OTHER
Responsible Party
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Hadassah Medical Center, Jerusalem, Israel
Principal Investigators
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DAVID GOZAL, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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ARIK TZUKERT, DMD
Role: primary
HADASS LEMBERG, PhD
Role: backup
Other Identifiers
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0452-08-HMO
Identifier Type: -
Identifier Source: org_study_id