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Macintosh and D-Blade® in Simulated Difficult Airway

Primary Purpose

Difficult Intubation, Cervical Injury Spine

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Macintosh blade
D-Blade
Intubation
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Difficult Intubation focused on measuring difficult airway, carvical collar, endotracheal intubation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Frankfurt

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

All patients received the same treatment. Laryngscopy with C-MAC PM + Macintosh blade Laryngscopy with C-MAC PM + D-Blade Intubation with C-MAC PM + D-Blade

Outcomes

Primary Outcome Measures

Best view of the glottic structures
Best view of the glottic structures according to the modified Cormack and Lehane (CL) scoring system

Secondary Outcome Measures

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
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®.

Full Information

First Posted
January 6, 2018
Last Updated
January 18, 2018
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03403946
Brief Title
Macintosh and D-Blade® in Simulated Difficult Airway
Official Title
Comparison of Direct and Indirect Laryngoscopy Using C-MAC PM® With Macintosh Blade and D-Blade® in Simulated Difficult Airway
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2011 (Actual)
Primary Completion Date
February 29, 2012 (Actual)
Study Completion Date
August 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Difficult Intubation, Cervical Injury Spine
Keywords
difficult airway, carvical collar, endotracheal intubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
All patients received the same treatment. Laryngscopy with C-MAC PM + Macintosh blade Laryngscopy with C-MAC PM + D-Blade Intubation with C-MAC PM + D-Blade
Intervention Type
Device
Intervention Name(s)
Macintosh blade
Intervention Description
Laryngoscopy with C-MAC PM in combination with Macintosh blade
Intervention Type
Device
Intervention Name(s)
D-Blade
Intervention Description
Laryngoscopy with C-MAC PM in combination with D-Blade
Intervention Type
Device
Intervention Name(s)
Intubation
Intervention Description
Intubation with C-MAC PM in combination with D-Blade
Primary Outcome Measure Information:
Title
Best view of the glottic structures
Description
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 Outcome Measure Information:
Title
Evaluate the process of Intubation using a questionnaire
Description
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
Title
Subjective assessment of satisfaction using numeric rating scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haitham Mutlak, Dr. med.
Organizational Affiliation
Department of Anesthesia, Intensive Care Medicine and Pain Therapy
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31065384
Citation
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.
Results Reference
derived

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Macintosh and D-Blade® in Simulated Difficult Airway

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