NCT02344030

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

January 13, 2015

Last Update Submit

August 1, 2018

Conditions

Hypoxemia

Keywords

airwayvideolaryngoscope

Outcome Measures

Primary Outcomes (1)

  • comparison of different time for tracheal intubation

    We want to measure the time for tracheal intubation

    <2min

Study Arms (2)

standard blade

EXPERIMENTAL

Standard Blade: tracheal intubation with standard blade

Device: channeled bladeDevice: standard blade

channeled blade

EXPERIMENTAL

Channeled Blade: tracheal intubation with channeled blade

Device: channeled bladeDevice: standard blade

Interventions

channeled bladeDEVICE

In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve

channeled bladestandard blade
standard bladeDEVICE

In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve

channeled bladestandard blade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mainz, Rhineland-Palatinate, D55131, Germany

Location

Related Publications (3)

  • 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.

    PMID: 24742495RESULT

  • 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.

    PMID: 23812581RESULT

  • 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.

    PMID: 28859114DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Kriege, MD

    University JG, Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Marc Kriege, MD

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 22, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations

DE(1)