Macintosh and D-Blade® in Simulated Difficult Airway

Not Applicable

Completed

• Conditions: Difficult Intubation; Cervical Injury Spine
• Interventions: Device: Macintosh blade; Device: D-Blade; Device: Intubation

• Registration Number: NCT03403946
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2011-12-01
• Primary Completion: 2012-02-29
• Study Completion: 2012-08-31
• Status Verified: 2018-01
• Study First Submitted: 2018-01-06
• Study First Submitted QC: 2018-01-11
• Last Update Submitted: 2018-01-18
• Study First Posted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Intubation	All patients received the same treatment. 1. Laryngscopy with C-MAC PM + Macintosh blade 2. Laryngscopy with C-MAC PM + D-Blade 3. Intubation with C-MAC PM + D-Blade
Intervention	D-Blade	All patients received the same treatment. 1. Laryngscopy with C-MAC PM + Macintosh blade 2. Laryngscopy with C-MAC PM + D-Blade 3. Intubation with C-MAC PM + D-Blade
Intervention	Macintosh blade	All patients received the same treatment. 1. Laryngscopy with C-MAC PM + Macintosh blade 2. Laryngscopy with C-MAC PM + D-Blade 3. Intubation with C-MAC PM + D-Blade

Primary Outcome Measures

Name	Time	Method
Best view of the glottic structures	120 seconds after induction of narcosis	Best view of the glottic structures according to the modified Cormack and Lehane (CL) scoring system

Secondary Outcome Measures

Name	Time	Method
Evaluate the process of Intubation using a questionnaire	Directly after successful tracheal intubation	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
Subjective assessment of satisfaction using numeric rating scale	Directly after successful tracheal intubation	Finally, all investigators were asked for their subjective assessment from 0 = dissatisfied to 100 = fully satisfied when using the D-Blade®.

Trial Locations

Locations (1)

University Hospital Frankfurt; 🇩🇪 Frankfurt am Main, Hessen, Germany