Comparison of VieScope vs. Macintosh Laryngoscope for Intubation in Level Cpersonal Protective Equipment Conditions

April 24, 2020 updated by: Łukasz Szarpak, Lazarski University

Comparison of VieScope Versus Macintosh Laryngoscope for Emergency Intubation Under Level C Personal Protective Equipment Conditions

The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC for aerosol-generating procedures (AGP), medical personnel should be equipped with full personal protective equipment (PPE) for AGP. Therefore, it is reasonable to search for the most effective methods of intubation in those conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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
      • Warsaw, Poland, 02-662
        • Lazarski Univeristy

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:

  • paramedic
  • consent voluntary participation in the study
  • none experience in Vie Scope
  • none experience in intubation with personal protective equipment

Exclusion Criteria:

  • refusal to participate in the study

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: Regurgitation
intubation in regurgitation condition
Device: The standard Macintosh laryngoscope
intubation with the standard Macintosh laryngoscope and endotracheal tube 7.0 internal diameter with standard tube stylet
Other Names:
  • MAC
Device: The Vie Scope laryngoscope
intubation with the Vie Scope laryngoscope with bougie stylet and endotracheal tube 7.0 internal diameter
Other Names:
  • VSCOPE
Experimental: Tongue edema
intubation in Tongue edema condition
Device: The standard Macintosh laryngoscope
intubation with the standard Macintosh laryngoscope and endotracheal tube 7.0 internal diameter with standard tube stylet
Other Names:
  • MAC
Device: The Vie Scope laryngoscope
intubation with the Vie Scope laryngoscope with bougie stylet and endotracheal tube 7.0 internal diameter
Other Names:
  • VSCOPE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to intubation
Time Frame: 1 day
time from pick up device to the final placement tube in trachea
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the degree of visibility of the glottis
Time Frame: 1 day
The POGO score describes how much glottic opening is visible. A POGO score of 100% indicates visualization of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% corresponds with no visualization of laryngeal structures.
1 day
Cormack - Lehane grade
Time Frame: 1 day
self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)
1 day
success of intubation
Time Frame: 1 day
A failed intubation attempt was defined as an attempt in which the trachea was not intubated, or which required more than 120 seconds to perform
1 day
Number of optimalization maneuvers
Time Frame: 1 day
the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation
1 day
Procedure Ease of use
Time Frame: 1 day
self-reported percentage the vocal cord visualization. A 100% score is a extremely difficult procedure. A Ease of use score of 1% means that procedure is extremely easy
1 day

Collaborators and Investigators

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

Sponsor

Lazarski University

Collaborators

Poznan University of Medical Sciences
Wroclaw Medical University
Medical University of Bialystok

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 (Actual)

January 20, 2020

Primary Completion (Actual)

February 23, 2020

Study Completion (Actual)

February 25, 2020

Study Registration Dates

First Submitted

April 23, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INT_PPE_2020_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

we will decided after finishing manuscript

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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