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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04363775
Other study ID # INT_PPE_2020_1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2020
Est. completion date February 25, 2020

Study information

Verified date April 2020
Source Lazarski University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date February 25, 2020
Est. primary completion date February 23, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
The standard Macintosh laryngoscope
intubation with the standard Macintosh laryngoscope and endotracheal tube 7.0 internal diameter with standard tube stylet
The Vie Scope laryngoscope
intubation with the Vie Scope laryngoscope with bougie stylet and endotracheal tube 7.0 internal diameter

Locations

Country Name City State
Poland Lazarski Univeristy Warsaw

Sponsors (4)

Lead Sponsor Collaborator
Lazarski University Medical University of Bialystok, Poznan University of Medical Sciences, Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary time to intubation time from pick up device to the final placement tube in trachea 1 day
Secondary success of intubation 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
Secondary Number of optimalization maneuvers the number of optimization maneuvers required (re-adjustment of head position, second assistant) to aid endotracheal intubation 1 day
Secondary Procedure Ease of use 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
Secondary the degree of visibility of the glottis 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
Secondary Cormack - Lehane grade self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4) 1 day
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