Videolaryngoscopes for Tracheal Intubation

Comparison Between Imago V-Blade and Glidescope During Endotracheal Intubation: a Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: Imago V-Balde; Device: Glidescope

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • University of Naples Federico II department of Anesthesia and Critical Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 77 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: endotracheal intubation with Imago V-blade; Patients in this arm will receive endotracheal intubation with the Imago V-Blade videolaryngoscopes.	Device: Imago V-Balde; the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual
Active Comparator: endotracheal intubation with Glidescope; Patients in this arm will receive endotracheal intubation with the glidescope videolaryngoscopes.	Device: Glidescope; the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
feasibility of endotracheal intubation	within 60 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of endotracheal intubation using Imago V-Blade compared with Glidescope	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	wthin 120 seconds
Intubation time	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	wthin 120 seconds
Cormack and Lehane score view		During endotracheal intubation
use of adjunctive maneuvers to aid the 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	During endotracheal intubation
Intubation difficulty scale score	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	within 60 seconds

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Vargas M, Pastore A, Aloj F, Laffey JG, Servillo G. A comparison of videolaryngoscopes for tracheal intubation in predicted difficult airway: a feasibility study. BMC Anesthesiol. 2017 Feb 20;17(1):25. doi: 10.1186/s12871-017-0318-2.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Estimate): January 5, 2017
• Last Update Submitted That Met QC Criteria: January 4, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Intubation; Videolaryngoscopes
• Other Study ID Numbers: Airway1