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

NCT ID: NCT01635660

Last Updated: 2015-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intubation Intratracheal Airway Management Emergency Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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C-MAC System

Group Type ACTIVE_COMPARATOR

Intubation

Intervention Type DEVICE

Tracheal Intubation with the assigned video laryngoscope

AP Advance

Group Type ACTIVE_COMPARATOR

Intubation

Intervention Type DEVICE

Tracheal Intubation with the assigned video laryngoscope

King Vision

Group Type ACTIVE_COMPARATOR

Intubation

Intervention Type DEVICE

Tracheal Intubation with the assigned video laryngoscope

Interventions

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Intubation

Tracheal Intubation with the assigned video laryngoscope

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karl Storz Endoscopy, Germany

UNKNOWN

Sponsor Role collaborator

King Systems Corporation

INDUSTRY

Sponsor Role collaborator

LMA, Germany

UNKNOWN

Sponsor Role collaborator

Venner Medical, Germany

UNKNOWN

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Erol Cavus

PD Dr. med. Erol Cavus

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Klinikum LDW / NEF Bremen Süd

Bremen, , Germany

Site Status

Uniklinikum Greifswald / DRF Luftrettung

Greifswald, , Germany

Site Status

Uniklinikum Kiel / DRF Luftrettung

Rendsburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29239965 (View on PubMed)

Other Identifiers

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ANKIEL-VLS-2012-CAV

Identifier Type: -

Identifier Source: org_study_id

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