UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation

Study Overview
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Brief Summary
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The present randomized clinical trial wants to compare the efficacy and safety of UED-A videolaryngoscope to Glidescope Titanium for routinely tracheal intubation in 60 adults, in terms of successful rate, no. attempts and manoeuvre duration.

Official Title
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UED-A Videolaryngoscope vs. Glidescope Titanium for Elective Tracheal Intubation: a Randomized Clinical Trial

Conditions
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Intubation; Difficult or Failed

Intervention / Treatment
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* Device: UED-A Videolaryngoscopy
* Device: Glidescope Videolaryngoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients candidates for general anesthesia in elective general surgery Age over 18 years American Society of Anesthesiologists (ASA) physical status I-III. Exclusion Criteria: Refusal to sign informed consent Paediatric population ASA physical status IV Emergency tracheal intubation Independent Predictors of difficult Videolaryngoscopy (Neck extension < 80°, macroglossia, interincisor distance < 3 cm, anatomical alterations of the neck, cardiac surgery, ear-nose-throat surgery)

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UED-A<br>Tracheal Intubation with UED-A videolaryngoscope | Device: UED-A Videolaryngoscopy<br>* Tracheal Intubation with UED-A videolaryngoscope<br>|
| Active Comparator: GLIDESCOPE<br>Tracheal Intubation with Glidescope Titanium videolaryngoscope | Device: Glidescope Videolaryngoscopy<br>* Tracheal Intubation with Glidescope Titanium videolaryngoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracheal intubation rate | Successful tracheal intubation rate | 30 minutes | 
| Number of attempts | Number of attempts for a successful tracheal intubation | 30 minutes | 
| Total time of intubation | Time needed to perform a tracheal intubation from the insertion of the video laryngoscope into the patient mouth | 15 minutes | 
| Time to glottis visualization | Time needed to visualize the glottis from the insertion of the video laryngoscope into the patient mouth | 15 minutes | 
| Cormack-Lehane grade | Cormack-Lehane grade observed at videolaryngoscopy Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen, none of glottis seen Grade 4: Neither glottis nor epiglottis seen | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of External laryngeal pressure | Rate of external laryngeal pressure during laryngoscopy | 15 minutes | 
| Rate of of post-laryngoscopy side effects | Rate of of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia) | 24 hours | 
| Rate of Desaturation | Rate of Desaturation (spO2 < 93%) during tracheal intubation attempts | 15 minutes | 
| Satisfaction Scale | Clinicians Satisfaction with the use of the videolaryngoscope, expressed by a 0-10 numeric rating scale (0 = the worst videolaryngoscopy ever performed; 10 = the best videolaryngoscopy ever performed) | 30 minutes |