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

Overview

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.

Full Title of Study: “A Randomized Comparison of Cervical Spine Motion During Tracheal Intubation Using Video Laryngoscope or Rigid Video Stylet in Patients With Simulated Cervical Immobilization”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 31, 2017

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.

Interventions

  • Device: rigid video stylet intubation
    • intubation using rigid video stylet
  • Device: video laryngoscope intubation
    • intubation using video laryngoscope

Arms, Groups and Cohorts

  • Experimental: Group A
    • rigid video stylet intubation – video laryngoscope intubation
  • Experimental: Group B
    • video laryngoscope intubation – rigid video stylet intubation

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tae Kyong Kim, Clinical Assistant Professor – Seoul National University Hospital
  • Overall Official(s)
    • Tae Kyong Kim, M.D., Ph. D., Principal Investigator, Seoul National University Hospital

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