Macintosh and D-Blade® in Simulated Difficult Airway

January 18, 2018 updated by: Dr. med. Florian Raimann, Johann Wolfgang Goethe University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • University Hospital Frankfurt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

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
Device: Macintosh blade
Laryngoscopy with C-MAC PM in combination with Macintosh blade
Device: D-Blade
Laryngoscopy with C-MAC PM in combination with D-Blade
Device: Intubation
Intubation with C-MAC PM in combination with D-Blade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
120 seconds after induction of narcosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the process of Intubation using a questionnaire
Time Frame: 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
Directly after successful tracheal intubation
Subjective assessment of satisfaction using numeric rating scale
Time Frame: 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®.
Directly after successful tracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Study Director: Haitham Mutlak, Dr. med., Department of Anesthesia, Intensive Care Medicine and Pain Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2011

Primary Completion (Actual)

February 29, 2012

Study Completion (Actual)

August 31, 2012

Study Registration Dates

First Submitted

January 6, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (Actual)

January 19, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 126/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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