Intubation Success Rate_Rigid Video Stylet Vs Video Laryngoscope

May 11, 2016 updated by: Hee-Pyoung Park, Seoul National University Hospital

Comparison of the Initial Intubation Success Rate Between Video Laryngoscope and Rigid Video Stylet in Patients Undergoing Cervical Spine Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

370

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of success rate between two groups
Time Frame: immediately
immediately

Secondary Outcome Measures

Outcome Measure
Time Frame
Survey of blood tinged endotracheal tube, bleeding in oral cavity, hoarseness, sore throat
Time Frame: Within 24 hours after endotracheal intubation
Within 24 hours after endotracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 10, 2016

First Posted (ESTIMATE)

May 11, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Rigid video stylet intubation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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