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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

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ClinicalTrials.gov Identifier: NCT00814424
Recruitment Status : Unknown
Verified December 2008 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2008
Last Update Posted : December 24, 2008
Sponsor:
Collaborator:
Oridion
Information provided by:
Hadassah Medical Organization

December 23, 2008
December 24, 2008
December 24, 2008
January 2009
May 2009   (Final data collection date for primary outcome measure)
EtCO2 measurement on the investigational device is equivalent to measurement on the control device [ Time Frame: 3 months ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Ventilatory Status of Deeply Sedated ERCP Patients
  • 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
  • Active Comparator: 1
    ERCP patients monitored using currently marketed smart biteblock o2
    Intervention: Device: monitored using currently marketed smart biteblock o2
  • Experimental: 2
    ERCP patients monitored using experimental biteblock delivering up to 10 lit/min oxygen
    Intervention: Device: monitored using investigational smart biteblock
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
70
July 2009
May 2009   (Final data collection date for primary outcome measure)

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: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00814424
0452-08-HMO
No
Not Provided
Not Provided
David Gozal MD, Director of Sedation, Hadassah Medical Center, Jerusalem, Israel
Hadassah Medical Organization
Oridion
Principal Investigator: DAVID GOZAL, M.D. Hadassah Medical Organization
Hadassah Medical Organization
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP