NCT04363775

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 23, 2020

Last Update Submit

April 24, 2020

Conditions

Keywords

SARS-CoV-2COVID-19tracheal intubationlaryngoscopepersonal protective equipment

Outcome Measures

Primary Outcomes (1)

  • time to intubation

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

    1 day

Secondary Outcomes (5)

  • success of intubation

    1 day

  • Number of optimalization maneuvers

    1 day

  • Procedure Ease of use

    1 day

  • the degree of visibility of the glottis

    1 day

  • Cormack - Lehane grade

    1 day

Study Arms (2)

Regurgitation

EXPERIMENTAL

intubation in regurgitation condition

Device: The standard Macintosh laryngoscopeDevice: The Vie Scope laryngoscope

Tongue edema

EXPERIMENTAL

intubation in Tongue edema condition

Device: The standard Macintosh laryngoscopeDevice: The Vie Scope laryngoscope

Interventions

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

Also known as: MAC
RegurgitationTongue edema

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

Also known as: VSCOPE
RegurgitationTongue edema

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lazarski Univeristy

Warsaw, 02-662, Poland

Location

MeSH Terms

Conditions

InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Profesor

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

January 20, 2020

Primary Completion

February 23, 2020

Study Completion

February 25, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations