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

Tracking Information

First Received Date ^ICMJE

December 23, 2008

Last Updated Date

December 23, 2008

Start Date ^ICMJE

January 2009

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Ventilatory Status of Deeply Sedated ERCP Patients

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2009

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00814424

Other Study ID Numbers ^ICMJE

0452-08-HMO

Has Data Monitoring Committee

Responsible Party

David Gozal MD, Director of Sedation, Hadassah Medical Center, Jerusalem, Israel

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Oridion

Investigators ^ICMJE

Principal Investigator:

DAVID GOZAL, M.D.

Hadassah Medical Organization

Information Provided By

Hadassah Medical Organization

Verification Date

December 2008

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

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