Double Lumen Tube Intubation (DLETI)

November 18, 2014 updated by: Lukasz Szarpak, International Institute of Rescue Research and Education

Comparison of Techniques for Double-lumen Tube Intubation: Standard Double-lumen Tube or VivaSight Double Lumen Tube by Paramedics. A Randomized Crossover Manikin Trial.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Masovia
      • Warsaw, Masovia, Poland, 03-122
        • Recruiting
        • International Institute of Rescue Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ETI intubation
endotracheal intubation in manikin
Device: standard double-lumen tube
intubation using standard double-lumen tube
Device: VivaSight Double Lumen Tube
intubation using VivaSight Double Lumen Tube

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Institute of Rescue Research and Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (ESTIMATE)

November 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETI/2014/43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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