Macintosh and D-Blade® in Simulated Difficult Airway

Study Overview
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Brief Summary
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In the presented study, our aim was to compare intubation conditions regarding the modified Cormack & Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.

Detailed Description
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Patients with unexpected difficult airway requiring endotracheal intubation (ETI) remain extremely challenging for emergency physicians and intubation failure with subsequent hypoxic complications still represents the majority of cases in a recent closed claims analysis. An incidence of major complications in airway management of 1 in 5,500 was estimated in the Fourth National Audit Project in the UK. Therefore, our aim was to compare intubation conditions regarding the modified Cormack & Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.

Official Title
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Comparison of Direct and Indirect Laryngoscopy Using C-MAC PM® With Macintosh Blade and D-Blade® in Simulated Difficult Airway

Conditions
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Difficult Intubation, Cervical Injury Spine

Intervention / Treatment
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* Device: Macintosh blade
* Device: D-Blade
* Device: Intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring general anesthesia for orthopedic surgery Exclusion Criteria: known or expected difficult airway undergoing urgent or emergent surgery non-fasted American Society of Anesthesiology Class (ASA) IV-VI no consent for participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

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
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>All patients received the same treatment. Laryngscopy with C-MAC PM + Macintosh blade Laryngscopy with C-MAC PM + D-Blade Intubation with C-MAC PM + D-Blade | Device: Macintosh blade<br>* Laryngoscopy with C-MAC PM in combination with Macintosh blade<br>Device: D-Blade<br>* Laryngoscopy with C-MAC PM in combination with D-Blade<br>Device: Intubation<br>* Intubation with C-MAC PM in combination with D-Blade<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best view of the glottic structures | Best view of the glottic structures according to the modified Cormack and Lehane (CL) scoring system | 120 seconds after induction of narcosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the process of Intubation using a questionnaire | As a secondary endpoint, all investigators were asked to evaluate the process of ETI with the D-Blade® from grade 1 to grade 4. Grade 1: Uncomplicated ETI with guide rod Grade 2: Challenging ETI, readjustment or usage of BURP necessary Grade 3: ETI using a stylet Grade 4: ETI failed | Directly after successful tracheal intubation | 
| Subjective assessment of satisfaction using numeric rating scale | Finally, all investigators were asked for their subjective assessment from 0 = dissatisfied to 100 = fully satisfied when using the D-Blade®. | Directly after successful tracheal intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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difficult airway, carvical collar, endotracheal intubation