Videolaryngoscopes for Tracheal Intubation

Overview

The primary end point of this study is the feasibility of intubation. The secondary end-points are the success to intubate in the first attempt, the intubation time, the Cormack and Lehane score view, the comparison of the intubation difficulty scale (IDS) score and the need for maneuvers to aid the endotracheal intubation comparing Imago V-Blade ® and Glidescope®. Patients admit to the operation rooms of University of Naples "Federico II" and requiring endotracheal intubation for general anesthesia will be consecutively screened for the presence of predicted difficult airway according Italian guideline. According to this guideline, the presence of one or more of the following parameters may be considered highly predictive of difficult intubation: Mallampati class 3-4, inter-incisor distance < 30 mm, mental-thyroidal distance < 60 mm, large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust, reduced head and neck motility, and reduced mental-jugular distance. Patients matching more then 1 of the previous criteria stated by Italian guideline will be included in this case controlled study. Patients 1) without criteria for predicted difficult airway; 2) those requiring emergency surgery; 3) aged < 18 years; or 4) declined consent to participate, will be excluded from this study.The primary end-point was the comparison of the intubation difficulty scale (IDS) score. The secondary end-points were the learning curve, the intubation time, the Cormack and Lehane score view, and the need for maneuvers to aid the endotracheal intubation comparing different videolaryngoscopes available in our department. Two anesthesiologists with 10 years of experience in conventional endotracheal intubation and trained for video assisted intubation will perform the maneuvers.

Full Title of Study: “Comparison Between Imago V-Blade and Glidescope During Endotracheal Intubation: a Feasibility Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2016

Interventions

  • Device: Imago V-Balde
    • the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual
  • Device: Glidescope
    • the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual

Arms, Groups and Cohorts

  • Experimental: endotracheal intubation with Imago V-blade
    • Patients in this arm will receive endotracheal intubation with the Imago V-Blade videolaryngoscopes.
  • Active Comparator: endotracheal intubation with Glidescope
    • Patients in this arm will receive endotracheal intubation with the glidescope videolaryngoscopes.

Clinical Trial Outcome Measures

Primary Measures

  • feasibility of endotracheal intubation
    • Time Frame: within 60 seconds

Secondary Measures

  • Success rate of endotracheal intubation using Imago V-Blade compared with Glidescope
    • Time Frame: wthin 120 seconds
    • Time to reach a successful endotracheal intubation from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide
  • Intubation time
    • Time Frame: wthin 120 seconds
    • time to reach endotracheal intubation from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide
  • Cormack and Lehane score view
    • Time Frame: During endotracheal intubation
  • use of adjunctive maneuvers to aid the endotracheal intubation
    • Time Frame: During endotracheal intubation
    • the investigators evaluated the necessary maneuvers to aid a successful endotracheal intubation as number of Readjusting patient’s head, number of external laryngeal pressure, number of advancement or withdrawal the blade and number of increased lifting force
  • Intubation difficulty scale score
    • Time Frame: within 60 seconds
    • Time to pass the vocal cord during the successful endotracheal intubation measured from the beginning of indirect laryngoscopy to the confirmation of the intubation with the evaluation of the end-tidal carbon dioxide

Participating in This Clinical Trial

Inclusion Criteria

  • Age>18 years – Mallampati class 3-4 – inter-incisor distance < 30 mm – mental-thyroidal distance < 60 mm – large prominence of superior incisors above inferior incisors uncorrectable with jaw-thrust -reduced head and neck motility – reduced mental-jugular distance. Exclusion Criteria:

  • < 1 criteria for predicted difficult airway – emergency surgery – age < 18 years – declined consent to participate

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 77 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federico II University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maria Vargas, MD – Federico II University

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