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

Airway Management Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635660
• Other study ID #: ANKIEL-VLS-2012-CAV
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: August 1, 2015
• Start date: October 2011
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: June 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Management
• Emergencies
• Emergency Treatment
• Intubation Intratracheal

Intervention

Device:
• Intubation
Tracheal Intubation with the assigned video laryngoscope

Locations

Country	Name	City	State
Germany	Klinikum LDW / NEF Bremen Süd	Bremen
Germany	Uniklinikum Greifswald / DRF Luftrettung	Greifswald
Germany	Uniklinikum Kiel / DRF Luftrettung	Rendsburg

Sponsors (5)

Lead Sponsor	Collaborator
University of Schleswig-Holstein	Karl Storz Endoscopy, Germany, King Systems Corporation, LMA, Germany, Venner Medical, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation success		Immediately after intubation	Yes
Secondary	Intubation on first attempt		Immediately after intubation	Yes
Secondary	Intubation time		Immediately after intubation	Yes