Videolaryngoscopes for Tracheal Intubation

Not Applicable

Completed

• Conditions: Airway Management
• Interventions: Device: Imago V-Balde; Device: Glidescope

• Registration Number: NCT02897518
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endotracheal intubation with Imago V-blade	Imago V-Balde	Patients in this arm will receive endotracheal intubation with the Imago V-Blade videolaryngoscopes.
endotracheal intubation with Glidescope	Glidescope	Patients in this arm will receive endotracheal intubation with the glidescope videolaryngoscopes.

Primary Outcome Measures

Name	Time	Method
feasibility of endotracheal intubation	within 60 seconds

Secondary Outcome Measures

Name	Time	Method
Cormack and Lehane score view	During endotracheal intubation
use of adjunctive maneuvers to aid the endotracheal intubation	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
Success rate of endotracheal intubation using Imago V-Blade compared with Glidescope	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 difficulty scale score	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
Intubation time	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

Trial Locations

Locations (1)

University of Naples Federico II department of Anesthesia and Critical Care; 🇮🇹 Naples, Italy