NCT00814424

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Ventilatory Status of Deeply Sedated ERCP Patients

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-05-01
• Completion: 2009-07-01
• First posted: 2008-12-24
• Last updated: 2008-12-24

Locations

1 site across 1 country: Israel