Macintosh and D-Blade® in Simulated Difficult Airway

Difficult Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403946
• Other study ID #: 126/11
• Status: Completed
• Phase: N/A
• First received: January 6, 2018
• Last updated: January 18, 2018
• Start date: December 1, 2011
• Est. completion date: August 31, 2012

Study information

• Verified date: January 2018
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 31, 2012
• Est. primary completion date: February 29, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Injury Spine
• Difficult Intubation

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best view of the glottic structures	Best view of the glottic structures according to the modified Cormack and Lehane (CL) scoring system	120 seconds after induction of narcosis
Secondary	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	Directly after successful tracheal intubation
Secondary	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®.	Directly after successful tracheal intubation