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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

NCT00814424 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2008-12-24

No results posted yet for this study

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 currently marketed smart bite block that delivers oxygen up to 5 liters/minute

Conditions

  • Ventilatory Status of Deeply Sedated ERCP Patients

Interventions

DEVICE

monitored using currently marketed smart biteblock o2

oral nasal CO2 monitoring and oxygen delivery

DEVICE

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

Sponsors & Collaborators

  • Oridion

    collaborator INDUSTRY

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • DAVID GOZAL, M.D. · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-05-31
Completion
2009-07-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00814424 on ClinicalTrials.gov