Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation

August 1, 2015 updated by: Erol Cavus, University Hospital Schleswig-Holstein

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

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

  • Germany
      • Bremen, Germany
        • Klinikum LDW / NEF Bremen Süd
      • Greifswald, Germany
        • Uniklinikum Greifswald / DRF Luftrettung
      • Rendsburg, Germany, 24768
        • Uniklinikum Kiel / DRF Luftrettung

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:

- 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

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
Active Comparator: C-MAC System
Device: Intubation
Tracheal Intubation with the assigned video laryngoscope
Active Comparator: AP Advance
Device: Intubation
Tracheal Intubation with the assigned video laryngoscope
Active Comparator: King Vision
Device: Intubation
Tracheal Intubation with the assigned video laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intubation success
Time Frame: Immediately after intubation
Immediately after intubation

Secondary Outcome Measures

Outcome Measure
Time Frame
Intubation on first attempt
Time Frame: Immediately after intubation
Immediately after intubation
Intubation time
Time Frame: Immediately after intubation
Immediately after intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Collaborators

King Systems Corporation
Karl Storz Endoscopy, Germany
LMA, Germany
Venner Medical, Germany

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

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

October 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 4, 2012

First Submitted That Met QC Criteria

July 6, 2012

First Posted (Estimate)

July 9, 2012

Study Record Updates

Last Update Posted (Estimate)

August 4, 2015

Last Update Submitted That Met QC Criteria

August 1, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANKIEL-VLS-2012-CAV

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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