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

Not Applicable

• Conditions: Ventilatory Status of Deeply Sedated ERCP Patients
• Interventions: Device: monitored using currently marketed smart biteblock o2; Device: monitored using investigational smart biteblock

• Registration Number: NCT00814424
• Lead Sponsor: Hadassah Medical Organization

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 available

Study Timeline

• Status Verified: 2008-12
• Study First Submitted: 2008-12-23
• Study First Submitted QC: 2008-12-23
• Last Update Submitted: 2008-12-23
• Study First Posted: 2008-12-24
• Last Update Posted: 2008-12-24
• Study Start: 2009-01
• Primary Completion: 2009-05
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	monitored using currently marketed smart biteblock o2	ERCP patients monitored using currently marketed smart biteblock o2
2	monitored using investigational smart biteblock	ERCP patients monitored using experimental biteblock delivering up to 10 lit/min oxygen

Primary Outcome Measures

Name	Time	Method
EtCO2 measurement on the investigational device is equivalent to measurement on the control device	3 months

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel