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

Ventilatory Status of Deeply Sedated ERCP Patients Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00814424
• Other study ID #: 0452-08-HMO
• Status: Not yet recruiting
• Phase: N/A
• First received: December 23, 2008
• Last updated: December 23, 2008
• Start date: January 2009
• Est. completion date: July 2009

Study information

• Verified date: December 2008
• Source: Hadassah Medical Organization
• Contact: DAVID GOZAL, M.D.
• Phone: 00 972 2 6777752
• Email: DAVIDGOZAL[@]YAHOO.COM
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• Ventilatory Status of Deeply Sedated ERCP Patients

Intervention

Device:
• monitored using currently marketed smart biteblock o2
oral nasal CO2 monitoring and oxygen delivery
• 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

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Oridion

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EtCO2 measurement on the investigational device is equivalent to measurement on the control device		3 months	No