Double Lumen Tube Intubation | NCT02295657

Studies
Double Lumen Tube Intubation

NCT02295657

Sponsor

International Institute of Rescue Research and Education

Status

Unknown status

Last Update Posted

Nov 20, 2014Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Endotracheal Intubation
Cardiac Arrest

Interventions

standard double-lumen tube
VivaSight Double Lumen Tube

Countries

Poland

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

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Nov 18, 2014

First Submission Date that Met QC Criteria

Nov 18, 2014

First Posted Date

Nov 20, 2014Estimated

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

Nov 18, 2014

Last Update Posted Date

Nov 20, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lukasz Szarpak, Lukasz Szarpak, National Institute of Cardiology, Warsaw, PolandPrincipal Investigator

Lead Sponsor

International Institute of Rescue Research and EducationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of this study was to compare time, success rates of different double-lumen tubes in intubation in a standardized manikin model.

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ETI intubation	Experimental	endotracheal intubation in manikin	Device: standard double-lumen tube Device: VivaSight Double Lumen Tube

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard double-lumen tube	Device	intubation using standard double-lumen tube	ETI intubation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success of intubation	effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants	1 day

Secondary Outcomes

Measure	Description	Time Frame
Intubation time	time in seconds required for a successful intubation attempt	1 day
Cormack-Lehane grading	self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

give voluntary consent to participate in the study
minimum 1 year of work experience in emergency medicine
experienced emergency medicine personnel (physicians, nurses, paramedics)

Exclusion Criteria:

not meet the above criteria
wrist or low back diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrzej Kurowski	Contact	+48500186225		andrzejkurowski987@gmail.com

Overall Officials

Name	Affiliation	Role
Lukasz Szarpak	Institute of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
International Institute of Rescue Research and Education	Recruiting	Warsaw	Masovia	03-122	Poland

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided