Ventilatory Status of Deeply Sedated ERCP PatientsNCT00814424
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
A study testing monitored using currently marketed smart biteblock o2 and monitored using investigational smart biteblock in people with Ventilatory Status of Deeply Sedated ERCP Patients, run by Hadassah Medical Organization at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ventilatory Status of Deeply Sedated ERCP Patients
- What is being tested?
- monitored using currently marketed smart biteblock o2 and monitored using investigational smart biteblock
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, 91120
ARIK TZUKERT, DMD, 00 972 2 6776095, arik@hadassah.org.il
HADASS LEMBERG, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
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
- Being tested
- monitored using currently marketed smart biteblock o2, monitored using investigational smart biteblock
- Keywords
- EtCO2, supplemental oxygen delivery, ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitored using currently marketed smart biteblock o2Device
oral nasal CO2 monitoring and oxygen delivery
monitored using investigational smart biteblockDevice
monitored during ERCP procedure with nasal CO2 sampling and oral oxygen delivery at a flow rate up to 10 lit/min
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ERCP patients monitored using currently marketed smart biteblock o2 Receives: Device: monitored using currently marketed smart biteblock o2 |
| 2 | Experimental | ERCP patients monitored using experimental biteblock delivering up to 10 lit/min oxygen Receives: Device: monitored using investigational smart biteblock |
What is being measured
The primary outcome is the main question the study is designed to answer.
EtCO2 measurement on the investigational device is equivalent to measurement on the control device
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilatory Status of Deeply Sedated ERCP PatientsStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Oridion
- Investigators
- DAVID GOZAL, M.D., Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814424
- Sponsor's protocol ID
- 0452-08-HMO
- Status last verified
- Dec 2008
- First submitted
- 23 Dec 2008
- Last updated
- 24 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00814424
- Acronym / sponsor ID
- 0452-08-HMO
- Keywords
- EtCO2, supplemental oxygen delivery, ERCP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Oridion
- Study start
- Jan 2009
- Primary completion
- May 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 24 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: monitored using currently marketed smart biteblock o2ERCP patients monitored using currently marketed smart biteblock o2 |
| 2 | Experimental | Device: monitored using investigational smart biteblockERCP patients monitored using experimental biteblock delivering up to 10 lit/min oxygen |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monitored using currently marketed smart biteblock o2oral nasal CO2 monitoring and oxygen delivery | Device | 1 |
| monitored using investigational smart biteblockmonitored during ERCP procedure with nasal CO2 sampling and oral oxygen delivery at a flow rate up to 10 lit/min | Device | 2 |
Primary outcome
EtCO2 measurement on the investigational device is equivalent to measurement on the control device
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DAVID GOZAL, M.D. principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monitored using currently marketed smart biteblock o2 and monitored using investigational smart biteblock in people with Ventilatory Status of Deeply Sedated ERCP Patients, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DAVID GOZAL, M.D. (00 972 2 6777752, DAVIDGOZAL@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EtCO2 measurement on the investigational device is equivalent to measurement on the control device (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2008.