Macintosh and D-Blade® in Simulated Difficult Airway

Johann Wolfgang Goethe University Hospital48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Enrollment

Conditions

Difficult Intubation Cervical Injury Spine

Interventions

Macintosh bladeDEVICE

Laryngoscopy with C-MAC PM in combination with Macintosh blade

D-BladeDEVICE

Laryngoscopy with C-MAC PM in combination with D-Blade

IntubationDEVICE

Intubation with C-MAC PM in combination with D-Blade

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

Outcomes

Primary Outcomes

Best view of the glottic structures

Best view of the glottic structures according to the modified Cormack and Lehane (CL) scoring system

Time frame: 120 seconds after induction of narcosis

Secondary Outcomes

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

Time frame: 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®.

Time frame: Directly after successful tracheal intubation

Data from ClinicalTrials.gov

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