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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00814424

Enrollment

Registered

2008-12-24

Start date

2009-01-31

Completion date

2009-07-31

Last updated

2008-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilatory Status of Deeply Sedated ERCP Patients

Keywords

EtCO2, supplemental oxygen delivery, ERCP

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

Interventions

DEVICEmonitored using currently marketed smart biteblock o2

oral nasal CO2 monitoring and oxygen delivery

DEVICEmonitored 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame
EtCO2 measurement on the investigational device is equivalent to measurement on the control device	3 months

Countries

Israel

Contacts

Primary ContactDAVID GOZAL, M.D.

DAVIDGOZAL@YAHOO.COM00 972 2 6777752

Backup ContactMURIEL COHEN, MSc

MURIEL@HADASSAH.ORG.IL00 972 2 6777752

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026