Cervical Spine Motion During Tracheal Intubation: Video Laryngoscope vs Rigid Video Stylet

February 12, 2018 updated by: Tae Kyong Kim, Seoul National University Hospital

A Randomized Comparison of Cervical Spine Motion During Tracheal Intubation Using Video Laryngoscope or Rigid Video Stylet in Patients With Simulated Cervical Immobilization

In this study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In patients with an unstable cervical spine, neck extension during tracheal intubation may result in harmful events such as spinal cord injury. Thus, it is important to minimize cervical spine motion in these patients. In this randomized crossover study, investigators are going to compare cervical spine motion during tracheal intubation using video laryngoscope or rigid video stylet in patients with simulated cervical immobilization.

Study Type

Interventional

Enrollment (Actual)

22

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.

Study Locations

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18-80 years undergoing elective endovascular cerebral aneurysm coiling to general anesthesia in a neuroangiography suite

Exclusion Criteria:

  • Patients with upper airway abnormalities such as inflammation, abscesses, tumors, polyps, and trauma
  • Patients with a medical history of gastroesophageal reflux disease and previous airway surgery, at high risk for aspiration, coagulation disorders, or a Hunt Hess grade of 3-5

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
rigid video stylet intubation - video laryngoscope intubation
Device: rigid video stylet intubation
intubation using rigid video stylet
Device: video laryngoscope intubation
intubation using video laryngoscope
EXPERIMENTAL: Group B
video laryngoscope intubation - rigid video stylet intubation
Device: rigid video stylet intubation
intubation using rigid video stylet
Device: video laryngoscope intubation
intubation using video laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum cervical spine motion
Time Frame: during tracheal intubation
maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments
during tracheal intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intubation time
Time Frame: during tracheal intubation
time interval between insertion of the device into the oral cavity and its removal
during tracheal intubation
number of intubation trial
Time Frame: during tracheal intubation
number of intubation trial
during tracheal intubation

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Tae Kyong Kim, M.D., Ph. D., Seoul National University Hospital

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 (ACTUAL)

July 25, 2017

Primary Completion (ACTUAL)

October 31, 2017

Study Completion (ACTUAL)

October 31, 2017

Study Registration Dates

First Submitted

April 14, 2017

First Submitted That Met QC Criteria

April 14, 2017

First Posted (ACTUAL)

April 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • McGrath vs Optiscope

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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