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Clinical Trials/NCT03403946
NCT03403946
Completed
Not Applicable

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

Johann Wolfgang Goethe University Hospital1 site in 1 country48 target enrollmentDecember 1, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Difficult Intubation
Sponsor
Johann Wolfgang Goethe University Hospital
Enrollment
48
Locations
1
Primary Endpoint
Best view of the glottic structures
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2011
End Date
August 31, 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Johann Wolfgang Goethe University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr. med. Florian Raimann

Principal Investigator

Johann Wolfgang Goethe University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Best view of the glottic structures

Time Frame: 120 seconds after induction of narcosis

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

Secondary Outcomes

  • Evaluate the process of Intubation using a questionnaire(Directly after successful tracheal intubation)
  • Subjective assessment of satisfaction using numeric rating scale(Directly after successful tracheal intubation)

Study Sites (1)

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