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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04363775
• Other study ID #: INT_PPE_2020_1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Infection
• Projection
• Tracheal Intubation

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