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OpenTrials
Completed

NCT Number: NCT04363775

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

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Key information

Conditions

Tracheal Intubation COVID-19 Coronaviridae Infections Coronavirus Infections Infection Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Projection RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lazarski Univeristy

Warsaw, 02-662, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The standard Macintosh laryngoscope

Device

intubation with the standard Macintosh laryngoscope and endotracheal tube 7.0 internal diameter with standard tube stylet

Other names: MAC

The Vie Scope laryngoscope

Device

intubation with the Vie Scope laryngoscope with bougie stylet and endotracheal tube 7.0 internal diameter

Other names: VSCOPE

Primary outcomes

  1. time to intubation

    Time frame: 1 day

    time from pick up device to the final placement tube in trachea

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. Cormack - Lehane grade

    Time frame: 1 day

    self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4)

Sponsors and collaborators

Lead sponsor

Lazarski University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2020
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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