NCT04365608

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

March 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2020

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

April 24, 2020

Last Update Submit

December 17, 2020

Conditions

Intubation ComplicationIntubation; Difficult or FailedCardiac ArrestInfluenzaSafety Issues

Keywords

endotracheal intubationcardiac arrestpersonal protective equipmentlaryngoscopeVie ScopeCOVID-19SARS-CoV-2emergency medicine

Outcome Measures

Primary Outcomes (1)

  • Intubation success rate during at the first laryngoscopy

    Definition of failed intubation: Time to intubation is longer than 120 seconds or wrong placement of endotracheal tube (For example : Esophageal intubation etc.)

    10 min

Secondary Outcomes (6)

  • Intubation difficulty Scale score

    10 min

  • Complications related to tracheal intubation

    10 min

  • Time to completion of tracheal intubation (TI) procedure

    10 min

  • Duration of the interruption of chest compression during ETI procedure

    10 min

  • Laryngeal View during intubation

    10 min

  • +1 more secondary outcomes

Study Arms (2)

Direct laryngoscopy

ACTIVE COMPARATOR

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.

Procedure: Direct laryngoscopy

Vie Scope laryngoscopy

ACTIVE COMPARATOR

Intubation will be done using Vie Scope laryngoscopy

Procedure: Vie Scope laryngoscopy

Interventions

Direct laryngoscopyPROCEDURE

standard laryngoscope with Macintosh blade

Also known as: MAC
Direct laryngoscopy
Vie Scope laryngoscopyPROCEDURE

Vie Scope with dedicated bougie stylet

Also known as: VCE
Vie Scope laryngoscopy

Eligibility Criteria

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

You may qualify if:

  • All adult patients requiring out-of-hospital intubation

You may not qualify if:

  • Patient under 18 years old
  • Patients with criteria predictive of impossible intubation under direct laryngoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Emergency Medical Service

Poznan, Poland

Location

Emergency Medical Service

Warsaw, Poland

Location

Related Publications (1)

  • 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.

    PMID: 35016094DERIVED

MeSH Terms

Conditions

Heart ArrestInfluenza, HumanCOVID-19

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsLung Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof PhD

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

March 20, 2020

Primary Completion

November 30, 2020

Study Completion

December 10, 2020

Last Updated

December 19, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR
Time Frame
after manuscript publishing

Locations

PL(2)