- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02344030
Comparsion of King Vision® Standard Blade and King Vision® Channeled Blade in Patients Scheduled for Tracheal Intubation (KingVision)
August 1, 2018 updated by: Marc Kriege, MD, Johannes Gutenberg University Mainz
Comparative Study of King Vision® Standard Blade and King Vision® Channeled for Tracheal Intubation: a Prospective Randomised Study
Comparison of intubation time from the time to fix the Trachealtube to the first end-tidal CO2 ventilation by means of the curve on the ventilator at KV standard blade and KV channeled blade
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In the proposed clinical trial the time measured until the first manual ventilation at 44 study participants with elective anesthesia by using the KV standard blade and KV channeled blade.
Bedside the time for tracheal intubation, we documented the view on the monitor which is connected to the instrument, the C& L classification and POGO Scale.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Germany, D55131
- Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 Years No concurrent participation in another study
- capacity to consent
- Present written informed consent of the research participant
- Elective surgery under general anesthesia
Exclusion Criteria:
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
- Emergency situations in the context of a Difficult Airway Management
- ASA classification> 3
- situations where the possibility of accumulated gastric contents
- Participation in another study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: standard blade
Standard Blade: tracheal intubation with standard blade
|
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
|
Experimental: channeled blade
Channeled Blade: tracheal intubation with channeled blade
|
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
comparison of different time for tracheal intubation
Time Frame: <2min
|
We want to measure the time for tracheal intubation
|
<2min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marc Kriege, MD, University JG, Mainz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Murphy LD, Kovacs GJ, Reardon PM, Law JA. Comparison of the king vision video laryngoscope with the macintosh laryngoscope. J Emerg Med. 2014 Aug;47(2):239-46. doi: 10.1016/j.jemermed.2014.02.008. Epub 2014 Apr 16.
- Akihisa Y, Maruyama K, Koyama Y, Yamada R, Ogura A, Andoh T. Comparison of intubation performance between the King Vision and Macintosh laryngoscopes in novice personnel: a randomized, crossover manikin study. J Anesth. 2014 Feb;28(1):51-7. doi: 10.1007/s00540-013-1666-9. Epub 2013 Jun 30.
- Kriege M, Alflen C, Noppens RR. Using King Vision video laryngoscope with a channeled blade prolongs time for tracheal intubation in different training levels, compared to non-channeled blade. PLoS One. 2017 Aug 31;12(8):e0183382. doi: 10.1371/journal.pone.0183382. eCollection 2017.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
January 13, 2015
First Submitted That Met QC Criteria
January 21, 2015
First Posted (Estimate)
January 22, 2015
Study Record Updates
Last Update Posted (Actual)
August 3, 2018
Last Update Submitted That Met QC Criteria
August 1, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JohannesGUKV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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