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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Oridion
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00814424
First received: December 23, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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


Condition Intervention
Ventilatory Status of Deeply Sedated ERCP Patients
 Device: monitored using currently marketed smart biteblock o2
Device: monitored using investigational smart biteblock

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • EtCO2 measurement on the investigational device is equivalent to measurement on the control device [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ERCP patients monitored using currently marketed smart biteblock o2
 Device: monitored using currently marketed smart biteblock o2
oral nasal CO2 monitoring and oxygen delivery
Experimental: 2
ERCP patients monitored using experimental biteblock delivering up to 10 lit/min oxygen
 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814424

Contacts
Contact: DAVID GOZAL, M.D. 00 972 2 6777752 DAVIDGOZAL@YAHOO.COM
Contact: MURIEL COHEN, MSc 00 972 2 6777752 MURIEL@HADASSAH.ORG.IL

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: ARIK TZUKERT, DMD     00 972 2 6776095     arik@hadassah.org.il    
Contact: HADASS LEMBERG, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Principal Investigator: DAVID GOZAL, M.D.            
Sponsors and Collaborators
Hadassah Medical Organization
Oridion
Investigators
Principal Investigator: DAVID GOZAL, M.D. Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: David Gozal MD, Director of Sedation, Hadassah Medical Center, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00814424     History of Changes
Other Study ID Numbers: 0452-08-HMO
Study First Received: December 23, 2008
Last Updated: December 23, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Hadassah Medical Organization:
EtCO2
supplemental oxygen delivery
ERCP

ClinicalTrials.gov processed this record on May 16, 2013