Back to resultsOut-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation
Primary Purpose
Intubation Intratracheal, Airway Management, Emergency Treatment
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intubation
Sponsored by
About this trial
This is an interventional treatment trial for Intubation Intratracheal focused on measuring Out-of-hospital, airway management, intubation, video laryngoscope
Eligibility Criteria
Inclusion Criteria:
- All adult emergency patients, age 18 years and older for whom a preclinical emergency intubation is necessary
Exclusion Criteria:
- Age under 18 years
- Laryngoscopy according to the algorithm of airway management not being indicated
Sites / Locations
- Klinikum LDW / NEF Bremen Süd
- Uniklinikum Greifswald / DRF Luftrettung
- Uniklinikum Kiel / DRF Luftrettung
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
C-MAC System
AP Advance
King Vision
Arm Description
Outcomes
Primary Outcome Measures
Intubation success
Secondary Outcome Measures
Intubation on first attempt
Intubation time
Full Information
NCT ID
NCT01635660
First Posted
July 4, 2012
Last Updated
August 1, 2015
Sponsor
University Hospital Schleswig-Holstein
Collaborators
Karl Storz Endoscopy, Germany, King Systems Corporation, LMA, Germany, Venner Medical, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01635660
Brief Title
Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation
Official Title
Prospective, Randomized, Multicentre Evaluation of Different Video-assisted, for Emergency Use Designed Intubation Aids for Out-of-hospital Endotracheal Intubation. Comparison of C-MAC System PM (Karl Storz), AP Advance (Venner Medical), and King Vision (King Systems) at Four German HEMS.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
Karl Storz Endoscopy, Germany, King Systems Corporation, LMA, Germany, Venner Medical, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research project examines the effectiveness of different video laryngoscopes in a out-of-hospital emergency intubation. Since in preclinical airway management severe incidents with esophageal failures of intubation may partly happen or rather endotracheal Intubation may completely fail, it is of great importance to evaluate alternative ways of endotracheal intubation in out-of-hospital emergency medicine. Video laryngoscopy has been proven in everyday clinical practice and may clinically be superior in most situations when compared to endotracheal Intubation using a conventional laryngoscope. No data exist, if different video laryngoscope types perform differently in the out-of-hospital setting. The investigators hypothesize that there would be no difference with regard to intubation time, intubation success, and intubation morbidity between different models of video laryngoscopes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation Intratracheal, Airway Management, Emergency Treatment
Keywords
Out-of-hospital, airway management, intubation, video laryngoscope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C-MAC System
Arm Type
Active Comparator
Arm Title
AP Advance
Arm Type
Active Comparator
Arm Title
King Vision
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Intubation
Intervention Description
Tracheal Intubation with the assigned video laryngoscope
Primary Outcome Measure Information:
Title
Intubation success
Time Frame
Immediately after intubation
Secondary Outcome Measure Information:
Title
Intubation on first attempt
Time Frame
Immediately after intubation
Title
Intubation time
Time Frame
Immediately after intubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- All adult emergency patients, age 18 years and older for whom a preclinical emergency intubation is necessary
Exclusion Criteria:
Age under 18 years
Laryngoscopy according to the algorithm of airway management not being indicated
Facility Information:
Facility Name
Klinikum LDW / NEF Bremen Süd
City
Bremen
Country
Germany
Facility Name
Uniklinikum Greifswald / DRF Luftrettung
City
Greifswald
Country
Germany
Facility Name
Uniklinikum Kiel / DRF Luftrettung
City
Rendsburg
ZIP/Postal Code
24768
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29239965
Citation
Cavus E, Janssen S, Reifferscheid F, Caliebe A, Callies A, von der Heyden M, Knacke PG, Doerges V. Videolaryngoscopy for Physician-Based, Prehospital Emergency Intubation: A Prospective, Randomized, Multicenter Comparison of Different Blade Types Using A.P. Advance, C-MAC System, and KingVision. Anesth Analg. 2018 May;126(5):1565-1574. doi: 10.1213/ANE.0000000000002735.
Results Reference
derived
Learn more about this trial
Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation
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