Out-of-Hospital Randomized Comparison of Video-assisted E... | NCT01635660

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

NCT01635660

Sponsor

University Hospital Schleswig-Holstein

Status

Completed

Last Update Posted

Aug 4, 2015Estimated

Enrollment

182Actual

Phase

Not Applicable

Conditions

Intubation Intratracheal
Airway Management
Emergency Treatment

Interventions

Intubation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jul 2014Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jul 4, 2012

First Submission Date that Met QC Criteria

Jul 6, 2012

First Posted Date

Jul 9, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2015

Last Update Posted Date

Aug 4, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erol Cavus, PD Dr. med. Erol Cavus, University Hospital Schleswig-HolsteinPrincipal Investigator

Lead Sponsor

University Hospital Schleswig-HolsteinOTHER

Collaborators

Name	Class
Karl Storz Endoscopy, Germany	UNKNOWN
King Systems Corporation	INDUSTRY
LMA, Germany	UNKNOWN
Venner Medical, Germany

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

182Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
C-MAC System	Active Comparator	Device: Intubation
AP Advance	Active Comparator	Device: Intubation
King Vision	Active Comparator	Device: Intubation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intubation	Device	Tracheal Intubation with the assigned video laryngoscope	AP Advance C-MAC System King Vision

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intubation success		Immediately after intubation

Secondary Outcomes

Measure	Description	Time Frame
Intubation on first attempt		Immediately after intubation
Intubation time		Immediately after intubation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum LDW / NEF Bremen Süd		Bremen			Germany
Uniklinikum Greifswald / DRF Luftrettung

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29239965	Derived	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.

ID	Term
D013812	Therapeutics
D008919	Investigative Techniques