Status:
UNKNOWN
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
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Oridion
Conditions:
Ventilatory Status of Deeply Sedated ERCP Patients
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 cur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00814424
Start Date
January 1 2009
End Date
July 1 2009
Last Update
December 24 2008
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120