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Completed

NCT Number: NCT03403946

Macintosh 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.

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Key information

Conditions

Difficult Intubation Cervical Injury Spine

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Macintosh Blade

Device

Laryngoscopy with C-MAC PM in combination with Macintosh blade

D-Blade

Device

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

Intubation

Device

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

Primary outcomes

  1. 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

  1. 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

  2. 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®.

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 19, 2018
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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