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Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

NCT ID: NCT04365608

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-20

Study Completion Date

2020-12-10

Brief Summary

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The safety and efficacy of a laryngoscopy as a primary intubation tool in urgent endotracheal intubation of cardiac arrest patients with suspected/confirmed COVID-19 has not been well-described in the literature. This study will answer whether using a Vie Scope laryngoscope will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.

Detailed Description

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Intubation will be carried out in full personal protective equipment conditions of the operator

Conditions

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Intubation Complication Intubation; Difficult or Failed Cardiac Arrest Influenza Safety Issues

Keywords

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endotracheal intubation cardiac arrest personal protective equipment laryngoscope Vie Scope COVID-19 SARS-CoV-2 emergency medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Direct laryngoscopy

Intubation will be done using direct laryngoscopy. The standard intubation procedure is to use a styletted tube and no sedation. When standard laryngoscopy-assisted intubation is not possible, an alternate procedure will be used based on the guidelines on difficult airway management.

Group Type ACTIVE_COMPARATOR

Direct laryngoscopy

Intervention Type PROCEDURE

standard laryngoscope with Macintosh blade

Vie Scope laryngoscopy

Intubation will be done using Vie Scope laryngoscopy

Group Type ACTIVE_COMPARATOR

Vie Scope laryngoscopy

Intervention Type PROCEDURE

Vie Scope with dedicated bougie stylet

Interventions

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Direct laryngoscopy

standard laryngoscope with Macintosh blade

Intervention Type PROCEDURE

Vie Scope laryngoscopy

Vie Scope with dedicated bougie stylet

Intervention Type PROCEDURE

Other Intervention Names

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MAC VCE

Eligibility Criteria

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Inclusion Criteria

* All adult patients requiring out-of-hospital intubation

Exclusion Criteria

* Patient under 18 years old
* Patients with criteria predictive of impossible intubation under direct laryngoscopy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poznan University of Medical Sciences

OTHER

Sponsor Role collaborator

Wroclaw Medical University

OTHER

Sponsor Role collaborator

Medical University of Bialystok

OTHER

Sponsor Role collaborator

Lazarski University

OTHER

Sponsor Role lead

Responsible Party

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Lukasz Szarpak

Assoc Prof PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Emergency Medical Service

Poznan, , Poland

Site Status

Emergency Medical Service

Warsaw, , Poland

Site Status

Countries

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Poland

References

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Szarpak L, Peacock FW, Rafique Z, Ladny JR, Nadolny K, Malysz M, Dabrowski M, Chirico F, Smereka J. Comparison of Vie Scope(R) and Macintosh laryngoscopes for intubation during resuscitation by paramedics wearing personal protective equipment. Am J Emerg Med. 2022 Mar;53:122-126. doi: 10.1016/j.ajem.2021.12.069. Epub 2022 Jan 4.

Reference Type DERIVED
PMID: 35016094 (View on PubMed)

Other Identifiers

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INT_EMS_PPE_1

Identifier Type: -

Identifier Source: org_study_id