Clincosm LogoSign in Get a demo

Intubation Success Rate_Rigid Video Stylet Vs Video Laryngoscope

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02769221
Collaborator
(none)
370
Enrollment
2
Arms
24
Duration (Months)

Study Details

Study Description

Brief Summary

This study compare the intubation success rate between video laryngoscope and rigid video stylet in cervical spine surgery patients. Half of patients will receive endotracheal intubation by video laryngscope, other half of patients will receive endotracheal intubation by rigid video laryngoscope.

Condition or Disease Intervention/Treatment Phase
  • Device: Rigid video stylet
  • Device: Video laryngoscope
 N/A

Detailed Description

Video laryngoscope and lightwand are widely used at endotracheal intubation in cervical spine patients.

Video laryngoscope is useful because of identification of anatomic structure around the oral cavity and vocal cord.

Rigid video stylet resemble lightwand, but it has a video at the end of stylet. So rigid video stylet is useful at confirmation of vocal cord.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
370 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of the Initial Intubation Success Rate Between Video Laryngoscope and Rigid Video Stylet in Patients Undergoing Cervical Spine Surgery
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Optiscope

Endotracheal intubation by rigid video stylet, manufactural named Optiscope.

Device: Rigid video stylet
Other Names:
  • Optiscope

    		•
    Active Comparator: McGrath

    Endotracheal intubation by video laryngoscope, manufactural named McGrath.

    Device: Video laryngoscope
    Other Names:
  • McGrath

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of success rate between two groups [immediately]

    Secondary Outcome Measures

    1. Survey of blood tinged endotracheal tube, bleeding in oral cavity, hoarseness, sore throat [Within 24 hours after endotracheal intubation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 20~80 years old adult patients, ASA class I-III

    • Cervical spine surgery in general anesthesia

    Exclusion Criteria:

    • Patients who did not agree with the study

    • History of GERD

    • Congenital or acquired lesion like tumor, polyp, trauma, abcess, inflammation, foreign body

    • Surgery of trachea or airway

    • History of radiation around neck area

    • Increased possibility of aspiration

    • Coagulation abnormality

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Hee-Pyoung Park, MD, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hee-Pyoung Park, MD, PhD, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02769221
    Other Study ID Numbers:
    • Rigid video stylet intubation
    First Posted:
    May 11, 2016
    Last Update Posted:
    May 13, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of May 13, 2016