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CompletedNCT03403946Updated Jan 23, 2018

Macintosh and D-Blade® in Simulated Difficult Airway

An interventional study of Macintosh blade and D-Blade in Difficult Intubation and Cervical Injury Spine, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Johann Wolfgang Goethe University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Difficult Intubation
  • Cervical Injury Spine

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Keywords

  • difficult airway
  • carvical collar
  • endotracheal intubation
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients requiring general anesthesia for orthopedic surgery

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrollment
48 participants (actual)

Study arms

  • 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 · Device: D-Blade · Device: Intubation

Interventions

  • DeviceMacintosh blade

    Laryngoscopy with C-MAC PM in combination with Macintosh blade

  • DeviceD-Blade

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

  • DeviceIntubation

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

05

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

06

Study locations

1 site
  • University Hospital Frankfurt
    Frankfurt am Main, Hessen 60590, Germany
07

References and documents

Publications

  • Raimann FJ, Dietze PE, Cuca CE, Meininger D, Kessler P, Byhahn C, Gill-Schuster D, Zacharowski K, Mutlak H. Prospective Trial to Compare Direct and Indirect Laryngoscopy Using C-MAC PM(R) with Macintosh Blade and D-Blade(R) in a Simulated Difficult Airway. Emerg Med Int. 2019 Apr 1;2019:1067473. doi: 10.1155/2019/1067473. eCollection 2019. PubMed 31065384 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03403946
Lead sponsor
Johann Wolfgang Goethe University Hospital
Responsible party
Dr. med. Florian Raimann (Principal Investigator, Johann Wolfgang Goethe University Hospital) — Principal investigator
First posted
Jan 19, 2018
Start date
Dec 1, 2011
Primary completion
Feb 29, 2012
Completion
Aug 31, 2012
Last update
Jan 23, 2018

Study contacts

Haitham Mutlak, Dr. med.
study director · Department of Anesthesia, Intensive Care Medicine and Pain Therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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