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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01974505
Other study ID # JejuNationalUniversityHospital
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 28, 2013
Last updated October 28, 2013
Start date November 2013
Est. completion date October 2014

Study information

Verified date October 2013
Source Jeju National University School of Medicine
Contact Hyun Jung Kim, MD, PhD
Phone 82-64-717-2026
Email hjanesthesia@empas.com
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- Patient who is scheduled general anesthesia for elective surgery

Exclusion Criteria:

- patient who is anticipated difficult airway

- patient who is needed rapid sequence induction

- Cervical injury

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
intubation using optiscope
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.

Locations

Country Name City State
Korea, Republic of Jeju National University Hospital Jeju-si Jeju Special Self-Governing Province

Sponsors (1)

Lead Sponsor Collaborator
Jeju National University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. intubation period No
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