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

Hadassah Medical Center

Status

Unknown

Conditions

Ventilatory Status of Deeply Sedated ERCP Patients

Treatments

Device: monitored using investigational smart biteblock

Device: monitored using currently marketed smart biteblock o2

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00814424

0452-08-HMO

Details and patient eligibility

About

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

Enrollment

70 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.