Videolaryngoscopes for Tracheal Intubation

Study Overview
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Brief Summary
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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.

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

Conditions
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Airway Management

Intervention / Treatment
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* Device: Imago V-Balde
* Device: Glidescope


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Videolaryngoscopes, Intubation