Intubation, IntratrachealNCT01974505
Learning Curve of Optiscope by Anesthesia Providers
A study testing intubation using optiscope in people with Intubation, Intratracheal, run by Jeju National University School of Medicine at 1 site in South Korea.
Trial summary
Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope for endotracheal intubation. This study will investigate learning curve of Optiscope by anesthesia providers. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- intubation using optiscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2013to Oct 2014
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient who is scheduled general anesthesia for elective surgery
Who cannot join
- patient who is anticipated difficult airway
- patient who is needed rapid sequence induction
- Cervical injury
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jeju National University Hospital
Jeju City, Jeju Special Self-Governing Province, 690-767
Jong Cook Park, professor, 82-64-717-2029, pjcook@cheju.ac.kr
Hyun Jung Kim, assistant professor
About this study
Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope for endotracheal intubation. This study will investigate learning curve of Optiscope by anesthesia providers.
- Conditions
- Intubation, Intratracheal
- Being tested
- intubation using optiscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubation using optiscopeDevice
Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope designed for endotracheal intubation. Anesthetic providers who are novice on optiscope will perform intubation using optiscope.
| Study group | Role | What they receive |
|---|---|---|
| intubation using optiscope | Experimental | The investigators are novice on optiscope. They will perform intubation using optiscope to patients scheduled elective surgery. Receives: Device: intubation using optiscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to intubation
Time to intubation (from optiscope insertion to the detection of end tidal CO2) will be recorded. If time to inubation is longer than 180 s or pulse oxymetry is lower than 94%, mask ventilation will be performed. If intubation is not successful within 3 trials, it will be performed using direct laryngoscope.
Measured: intubation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, IntratrachealStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeju National University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jung Kim, Jeju National University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974505
- Sponsor's protocol ID
- JejuNationalUniversityHospital
- Status last verified
- Oct 2013
- First submitted
- 28 Oct 2013
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve of Optiscope by Anesthesia Providers
- ClinicalTrials.gov ID
- NCT01974505
- Acronym / sponsor ID
- JejuNationalUniversityHospital
- Conditions
- Intubation, Intratracheal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Jeju National University School of MedicineUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 1 Nov 2013 (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.
Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope for endotracheal intubation. This study will investigate learning curve of Optiscope by anesthesia providers.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intubation using optiscope | Experimental | Device: intubation using optiscopeThe investigators are novice on optiscope. They will perform intubation using optiscope to patients scheduled elective surgery. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient who is scheduled general anesthesia for elective surgery
Key exclusion criteria (3 listed)
- patient who is anticipated difficult airway
- patient who is needed rapid sequence induction
- Cervical injury
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 |
|---|---|---|
| intubation using optiscopeOptiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope designed for endotracheal intubation. Anesthetic providers who are novice on optiscope will perform intubation using optiscope. | Device | intubation using optiscope |
Primary outcome
time to intubation
Time frame: intubation period
Time to intubation (from optiscope insertion to the detection of end tidal CO2) will be recorded. If time to inubation is longer than 180 s or pulse oxymetry is lower than 94%, mask ventilation will be performed. If intubation is not successful within 3 trials, it will be performed using direct laryngoscope.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intubation using optiscope in people with Intubation, Intratracheal, run by Jeju National University School of Medicine at 1 site in South Korea.
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 1 inclusion and 3 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 1 Nov 2013. 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 South Korea. 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 Hyun Jung Kim, MD, PhD (82-64-717-2026, hjanesthesia@empas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to intubation (time frame: intubation period). 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 1 Nov 2013.