NCT01974505

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

11 months

First QC Date

October 28, 2013

Last Update Submit

October 28, 2013

Conditions

Intubation, Intratracheal

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

intubation using optiscope

EXPERIMENTAL

The investigators are novice on optiscope. They will perform intubation using optiscope to patients scheduled elective surgery.

Device: intubation using optiscope

Interventions

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.

intubation using optiscope

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient who is scheduled general anesthesia for elective surgery

You may not qualify if:

  • patient who is anticipated difficult airway
  • patient who is needed rapid sequence induction
  • Cervical injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeju National University Hospital

Jeju City, Jeju Special Self-Governing Province, 690-767, South Korea

Location

Central Study Contacts

Hyun Jung Kim, MD, PhD

CONTACT

82-64-717-2026hjanesthesia@empas.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 1, 2013

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

KR(1)