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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00814424
• Collaborator: Oridion (Industry)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 11.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ventilatory Status of Deeply Sedated ERCP Patients	Device: monitored using currently marketed smart biteblock o2; Device: monitored using investigational smart biteblock	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jan 1, 2009
• Anticipated Primary Completion Date: May 1, 2009
• Anticipated Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. EtCO2 measurement on the investigational device is equivalent to measurement on the control device [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel	91120

Sponsors and Collaborators

• Hadassah Medical Organization
• Oridion

Investigators

• Principal Investigator: DAVID GOZAL, M.D., Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00814424
• Other Study ID Numbers: 0452-08-HMO
• First Posted: Dec 24, 2008
• Last Update Posted: Dec 24, 2008
• Last Verified: Dec 1, 2008

• Keywords provided by , ,: EtCO2; supplemental oxygen delivery; ERCP

Study Results

No Results Posted as of Dec 24, 2008