Conventional Double-lumen Tube vs VivaSight DL

April 15, 2016 updated by: Łukasz Szarpak, Medical University of Warsaw

Ability of Anesthesiologist to Placid a Double-lumen Tube. A Randomized Crossover Cadaver Study Comparing VivaSight DL and Conventional Double-lumen Tube

The investigators sought to compare the time to intubation and success rate of the endotracheal intubation using standard double-lumen tube and video tube ETView DL in an adult cadaver model in normal and difficult airway conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

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, 02-005
        • Medical University of Warsaw, Department of Emergency Medicine

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fresh adult cadavers

Exclusion Criteria:

  • cadavers with face injures

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal airway
intubation with normal airway Cormack-Lehane classivication I
Device: VivaSight DL
intubation using VivaSight DL tube
Device: conventional double-lumen tube
intubation using conventional double-lumen tube
Experimental: difficult airway
intubation with difficult airway Cormack-Lehane classivication III
Device: VivaSight DL
intubation using VivaSight DL tube
Device: conventional double-lumen tube
intubation using conventional double-lumen tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required for endotracheal intubation
Time Frame: 1 day
time from pick up the tube to first ventilation
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of intubation
Time Frame: 1 day
To access subjective opinion about the difficulty of each intubation method, participants were asked to rate it on a visual analog scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult).
1 day
Time required for visual confirmation of double lumen tube position position
Time Frame: 1 day
Time required for visual confirmation of double lumen tube position position
1 day
success rate of intubation attempt
Time Frame: 1 day
success rate of first intubation attempt
1 day

Collaborators and Investigators

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

Sponsor

Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 13, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 02/04/2016

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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