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

This study is not yet open for participant recruitment.

Verified by Hadassah Medical Organization, December 2008

Sponsors and Collaborators:	Hadassah Medical Organization Oridion
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00814424

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

MedlinePlus related topics: Animal Bites Endoscopy

Drug Information available for: Carbon dioxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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
1: Active Comparator ERCP patients monitored using currently marketed smart biteblock o2	Device: monitored using currently marketed smart biteblock o2 oral nasal CO2 monitoring and oxygen delivery
2: Experimental 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
JERUSALEM, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Oridion

Investigators

Principal Investigator:

DAVID GOZAL, M.D.

Hadassah Medical Organization,Jerusalem,Israel

More Information

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

Keywords provided by Hadassah Medical Organization:

EtCO2
supplemental oxygen delivery
ERCP

Study placed in the following topic categories:

Bites and Stings

ClinicalTrials.gov processed this record on January 15, 2009