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Double Lumen Tube Intubation (DLETI)

Primary Purpose

Endotracheal Intubation, Cardiac Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
standard double-lumen tube
VivaSight Double Lumen Tube
Sponsored by
International Institute of Rescue Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endotracheal Intubation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • International Institute of Rescue Research and EducationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ETI intubation

Arm Description

endotracheal intubation in manikin

Outcomes

Primary Outcome Measures

Success of intubation
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants

Secondary Outcome Measures

Intubation time
time in seconds required for a successful intubation attempt
Cormack-Lehane grading
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Preferred ETI device
participants were asked which method of ETI they would prefer in a real-life.

Full Information

First Posted
November 18, 2014
Last Updated
November 18, 2014
Sponsor
International Institute of Rescue Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT02295657
Brief Title
Double Lumen Tube Intubation
Acronym
DLETI
Official Title
Comparison of Techniques for Double-lumen Tube Intubation: Standard Double-lumen Tube or VivaSight Double Lumen Tube by Paramedics. A Randomized Crossover Manikin Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Institute of Rescue Research and Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotracheal Intubation, Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ETI intubation
Arm Type
Experimental
Arm Description
endotracheal intubation in manikin
Intervention Type
Device
Intervention Name(s)
standard double-lumen tube
Intervention Description
intubation using standard double-lumen tube
Intervention Type
Device
Intervention Name(s)
VivaSight Double Lumen Tube
Intervention Description
intubation using VivaSight Double Lumen Tube
Primary Outcome Measure Information:
Title
Success of intubation
Description
effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Intubation time
Description
time in seconds required for a successful intubation attempt
Time Frame
1 day
Title
Cormack-Lehane grading
Description
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
Time Frame
1 day
Title
Preferred ETI device
Description
participants were asked which method of ETI they would prefer in a real-life.
Time Frame
1day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrzej Kurowski
Phone
+48500186225
Email
andrzejkurowski987@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Organizational Affiliation
Institute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Institute of Rescue Research and Education
City
Warsaw
State/Province
Masovia
ZIP/Postal Code
03-122
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
Phone
+48500186225
Email
lukasz.szarpak@gmail.com
First Name & Middle Initial & Last Name & Degree
Lukasz Szarpak
First Name & Middle Initial & Last Name & Degree
Andrzej Kurowski
First Name & Middle Initial & Last Name & Degree
Lukasz Czyżewski

12. IPD Sharing Statement

Learn more about this trial

Double Lumen Tube Intubation

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