Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

Safety and Efficacy of Endotracheal Intubation by Paramedics in Suspected/Confirmed COVID-19 Patients Under Cardiac Arrest Using Vie Scope Laryngoscope

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.

Study Overview

• Status: Completed
• Conditions: Influenza; Cardiac Arrest; Intubation Complication; Intubation; Difficult or Failed; Safety Issues
• Intervention / Treatment: Procedure: Direct laryngoscopy; Procedure: Vie Scope laryngoscopy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland
    • Emergency Medical Service
  • Warsaw, Poland
    • Emergency Medical Service

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Direct laryngoscopy; standard laryngoscope with Macintosh blade; Other Names: MAC
Active Comparator: Vie Scope laryngoscopy; Intubation will be done using Vie Scope laryngoscopy	Procedure: Vie Scope laryngoscopy; Vie Scope with dedicated bougie stylet; Other Names: VCE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation difficulty Scale score	Intubation difficulty assessed by Intubation difficulty Scale score	10 min
Complications related to tracheal intubation	Complications related to tracheal intubation during advanced Cardiopulmonary Resuscitation (CPR): failure, esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, extubation	10 min
Time to completion of tracheal intubation (TI) procedure	Time to completion of tracheal intubation (TI) procedure measured from the instant that the laryngoscope blade touches the patient to the moment that the tracheal tube cuff is inflated	10 min
Duration of the interruption of chest compression during ETI procedure	Duration of the interruption of chest compression during ETI procedure	10 min
Laryngeal View during intubation	We will record the best laryngeal View during intubation. We will record according to the Cormack-Lehane Grade system.	10 min
POGO score	self-reported percentage of glottis opening (POGO) score	10 min

Collaborators and Investigators

• Sponsor: Lazarski University
• Collaborators: Poznan University of Medical Sciences; Wroclaw Medical University; Medical University of Bialystok

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; endotracheal intubation; COVID-19; cardiac arrest; laryngoscope; personal protective equipment; Vie Scope; emergency medicine
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Heart Arrest
• Other Study ID Numbers: INT_EMS_PPE_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: after manuscript publishing
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No