NCT01635660

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

October 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

July 4, 2012

Last Update Submit

August 1, 2015

Conditions

Intubation IntratrachealAirway ManagementEmergency Treatment

Keywords

Out-of-hospitalairway managementintubationvideo laryngoscope

Outcome Measures

Primary Outcomes (1)

  • Intubation success

    Immediately after intubation

Secondary Outcomes (2)

  • Intubation on first attempt

    Immediately after intubation

  • Intubation time

    Immediately after intubation

Study Arms (3)

C-MAC System

ACTIVE COMPARATOR
Device: Intubation

AP Advance

ACTIVE COMPARATOR
Device: Intubation

King Vision

ACTIVE COMPARATOR
Device: Intubation

Interventions

IntubationDEVICE

Tracheal Intubation with the assigned video laryngoscope

AP AdvanceC-MAC SystemKing Vision

Eligibility Criteria

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

You may qualify if:

  • \- All adult emergency patients, age 18 years and older for whom a preclinical emergency intubation is necessary

You may not qualify if:

  • Age under 18 years
  • Laryngoscopy according to the algorithm of airway management not being indicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Klinikum LDW / NEF Bremen Süd

Bremen, Germany

Location

Uniklinikum Greifswald / DRF Luftrettung

Greifswald, Germany

Location

Uniklinikum Kiel / DRF Luftrettung

Rendsburg, 24768, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29239965DERIVED

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

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
PD Dr. med. Erol Cavus

Study Record Dates

First Submitted

July 4, 2012

First Posted

July 9, 2012

Study Start

October 1, 2011

Primary Completion

July 1, 2014

Study Completion

June 1, 2015

Last Updated

August 4, 2015

Record last verified: 2015-08

Locations

DE(3)