Skip to content

Macintosh and D-Blade® in Simulated Difficult Airway

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03403946
Enrollment
48
Registered
2018-01-19
Start date
2011-12-01
Completion date
2012-08-31
Last updated
2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Intubation, Cervical Injury Spine

Keywords

difficult airway, carvical collar, endotracheal intubation

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.

Interventions

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

Sponsors

Johann Wolfgang Goethe University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Best view of the glottic structures120 seconds after induction of narcosisBest view of the glottic structures according to the modified Cormack and Lehane (CL) scoring system

Secondary

MeasureTime frameDescription
Evaluate the process of Intubation using a questionnaireDirectly after successful tracheal intubationAs 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 scaleDirectly after successful tracheal intubationFinally, all investigators were asked for their subjective assessment from 0 = dissatisfied to 100 = fully satisfied when using the D-Blade®.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026