Duble Lumen Intubation

Study Overview
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Brief Summary
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Intrabronal intubation is one of the basic methods of airway protection during cardiac surgery. The use of double-lumen tubes in the implementation of a standard method based on macintosh laryngoscope may cause the prolongation of the procedure especially in the case of difficult airways. The aim of the study was to match the effectiveness of endotracheal intubation using a standard Macontosh laryngskop and a normal double-lumen tube versus the ETView DL tube.

Official Title
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Evaluation of the Double-Lumen Tube Vivasight-DL vs. Standard Duble-lumen Tube in Normal and Difficult Airway Scenarios: A Prospective, Randomized, Crossover, Simulation Trial

Conditions
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Intubation;Difficult, Intubation; Difficult or Failed, Difficult Airway

Intervention / Treatment
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* Device: Standard double-lumen tube
* Device: Double-Lumen Tube Vivasight-DL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: anesthesiologist or a person in the course of specialization consent voluntary participation in the study Exclusion Criteria: refusal to participate in the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal airway<br>normal airway. the language has not been inflated. the instructor assessed the difficulty of intubation based on the Cormack - Lehane scale to the first degree | Device: Standard double-lumen tube<br>* intubation using standard double-lumen tube with Macintosh laryngoscope<br>Device: Double-Lumen Tube Vivasight-DL<br>* intubation using Double-Lumen Video Tube Vivasight-DL with Macintosh laryngoscope<br>|
| Experimental: Difficult airway<br>dofficult airway. Difficult airways were obtained by means of language inflation using a simulator control panel, so as to obtain the degree of intubation difficulty assessed by an independent anesthesiologist to the third degree according to the Cormack-Lehane scale | Device: Standard double-lumen tube<br>* intubation using standard double-lumen tube with Macintosh laryngoscope<br>Device: Double-Lumen Tube Vivasight-DL<br>* intubation using Double-Lumen Video Tube Vivasight-DL with Macintosh laryngoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation time | from taking of the intubation device to successful intubation | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to visualize the glottis | time defined as the time from taking laryngoscope in hand until you obtain visualize the glottis | 1 day | 
| success of the first intubation trial | effectiveness of the first attempt of intubation by participants using four intubation devices | 1 day | 
| overall success rate | effectiveness measured during a maximum of three intubation attempts, confirmed by a single lung ventilation test | 1 day | 
| the degree of visibility of the glottis | The POGO score describes how much glottic opening is visible. A POGO score of 100% indicates visualization of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% corresponds with no visualization of laryngeal structures. | 1 day | 
| Cormack - Lehane grade | self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4) | 1 day | 
| ease of use | To access subjective opinions about the difficulty of the each intubation method, participants were asked to give a rating on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 100 (extremely difficult). | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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double-lumen tube, ETView, medical simulation, anesthesiologist, difficult airway