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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2012
CompletedFirst Submitted
Initial submission to the registry
January 6, 2018
CompletedFirst Posted
Study publicly available on registry
January 19, 2018
CompletedJanuary 23, 2018
January 1, 2018
3 months
January 6, 2018
January 18, 2018
Conditions
Keywords
Outcome Measures
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
120 seconds after induction of narcosis
Secondary Outcomes (2)
Evaluate the process of Intubation using a questionnaire
Directly after successful tracheal intubation
Subjective assessment of satisfaction using numeric rating scale
Directly after successful tracheal intubation
Study Arms (1)
Intervention
EXPERIMENTALAll 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
Interventions
Eligibility Criteria
You may qualify if:
- Patients requiring general anesthesia for orthopedic surgery
You may not qualify if:
- known or expected difficult airway
- undergoing urgent or emergent surgery
- non-fasted
- American Society of Anesthesiology Class (ASA) IV-VI
- no consent for participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Related Publications (1)
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.
PMID: 31065384DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Haitham Mutlak, Dr. med.
Department of Anesthesia, Intensive Care Medicine and Pain Therapy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 6, 2018
First Posted
January 19, 2018
Study Start
December 1, 2011
Primary Completion
February 29, 2012
Study Completion
August 31, 2012
Last Updated
January 23, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share