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

NCT00814424 | Unknown

• 1 other identifier: 0452-08-HMO
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Ventilatory Status of Deeply Sedated ERCP Patients

Keywords

EtCO2; supplemental oxygen delivery; ERCP

Outcome Measures

Primary Outcomes (1)

• EtCO2 measurement on the investigational device is equivalent to measurement on the control device

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

ERCP patients monitored using currently marketed smart biteblock o2

Device: monitored using currently marketed smart biteblock o2

2

EXPERIMENTAL

ERCP patients monitored using experimental biteblock delivering up to 10 lit/min oxygen

Device: monitored using investigational smart biteblock

Interventions

monitored using currently marketed smart biteblock o2 DEVICE

oral nasal CO2 monitoring and oxygen delivery

1

monitored using investigational smart biteblock DEVICE

monitored during ERCP procedure with nasal CO2 sampling and oral oxygen delivery at a flow rate up to 10 lit/min

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Oridion: collaborator

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Study Officials

• DAVID GOZAL, M.D.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DAVID GOZAL, M.D.

CONTACT

00 972 2 6777752; DAVIDGOZAL@YAHOO.COM

MURIEL COHEN, MSc

CONTACT

00 972 2 6777752; MURIEL@HADASSAH.ORG.IL

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2008
• First Posted: December 24, 2008
• Study Start: January 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 24, 2008

Record last verified: 2008-12

Locations

IL (1)