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Comparsion of King Vision® Standard Blade and King Vision® Channeled Blade in Patients Scheduled for Tracheal Intubation (KingVision)

Primary Purpose

Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
channeled blade
standard blade
Sponsored by
Johannes Gutenberg University Mainz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxemia focused on measuring airway, videolaryngoscope

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

standard blade

channeled blade

Arm Description

Standard Blade: tracheal intubation with standard blade

Channeled Blade: tracheal intubation with channeled blade

Outcomes

Primary Outcome Measures

comparison of different time for tracheal intubation
We want to measure the time for tracheal intubation

Secondary Outcome Measures

Full Information

First Posted
January 13, 2015
Last Updated
August 1, 2018
Sponsor
Johannes Gutenberg University Mainz
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1. Study Identification

Unique Protocol Identification Number
NCT02344030
Brief Title
Comparsion of King Vision® Standard Blade and King Vision® Channeled Blade in Patients Scheduled for Tracheal Intubation
Acronym
KingVision
Official Title
Comparative Study of King Vision® Standard Blade and King Vision® Channeled for Tracheal Intubation: a Prospective Randomised Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johannes Gutenberg University Mainz

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia
Keywords
airway, videolaryngoscope

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard blade
Arm Type
Experimental
Arm Description
Standard Blade: tracheal intubation with standard blade
Arm Title
channeled blade
Arm Type
Experimental
Arm Description
Channeled Blade: tracheal intubation with channeled blade
Intervention Type
Device
Intervention Name(s)
channeled blade
Intervention Description
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
Intervention Type
Device
Intervention Name(s)
standard blade
Intervention Description
In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
Primary Outcome Measure Information:
Title
comparison of different time for tracheal intubation
Description
We want to measure the time for tracheal intubation
Time Frame
<2min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Kriege, MD
Organizational Affiliation
University JG, Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
City
Mainz
State/Province
Rhineland-Palatinate
ZIP/Postal Code
D55131
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24742495
Citation
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.
Results Reference
result
PubMed Identifier
23812581
Citation
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.
Results Reference
result
PubMed Identifier
28859114
Citation
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.
Results Reference
derived

Learn more about this trial

Comparsion of King Vision® Standard Blade and King Vision® Channeled Blade in Patients Scheduled for Tracheal Intubation

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