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Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

Primary Purpose

Intubation Complication, Intubation; Difficult or Failed, Cardiac Arrest

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Direct laryngoscopy

Vie Scope laryngoscopy

About this trial

This is an interventional treatment trial for Intubation Complication focused on measuring endotracheal intubation, cardiac arrest, personal protective equipment, laryngoscope, Vie Scope, COVID-19, SARS-CoV-2, emergency medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emergency Medical Service
Emergency Medical Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Direct laryngoscopy

Vie Scope laryngoscopy

Arm Description

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.

Intubation will be done using Vie Scope laryngoscopy

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Intubation difficulty Scale score

Intubation difficulty assessed by Intubation difficulty Scale score

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

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

Duration of the interruption of chest compression during ETI procedure

Laryngeal View during intubation

We will record the best laryngeal View during intubation. We will record according to the Cormack-Lehane Grade system.

POGO score

self-reported percentage of glottis opening (POGO) score

Full Information

NCT ID

NCT04365608

First Posted

April 24, 2020

Last Updated

December 17, 2020

Sponsor

Lazarski University

Collaborators

Poznan University of Medical Sciences, Wroclaw Medical University, Medical University of Bialystok

1. Study Identification

Unique Protocol Identification Number

NCT04365608

Brief Title

Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

March 20, 2020 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lazarski University

Collaborators

Poznan University of Medical Sciences, Wroclaw Medical University, Medical University of Bialystok

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Direct laryngoscopy

Arm Type

Active Comparator

Arm Description

Arm Title

Vie Scope laryngoscopy

Arm Type

Active Comparator

Arm Description

Intubation will be done using Vie Scope laryngoscopy

Intervention Type

Procedure

Intervention Name(s)

Direct laryngoscopy

Other Intervention Name(s)

MAC

Intervention Description

standard laryngoscope with Macintosh blade

Intervention Type

Procedure

Intervention Name(s)

Vie Scope laryngoscopy

Other Intervention Name(s)

VCE

Intervention Description

Vie Scope with dedicated bougie stylet

Primary Outcome Measure Information:

Title

Intubation success rate during at the first laryngoscopy

Description

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

Time Frame

10 min

Secondary Outcome Measure Information:

Title

Intubation difficulty Scale score

Description

Intubation difficulty assessed by Intubation difficulty Scale score

Time Frame

10 min

Title

Complications related to tracheal intubation

Description

Time Frame

10 min

Title

Time to completion of tracheal intubation (TI) procedure

Description

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

Time Frame

10 min

Title

Duration of the interruption of chest compression during ETI procedure

Description

Duration of the interruption of chest compression during ETI procedure

Time Frame

10 min

Title

Laryngeal View during intubation

Description

We will record the best laryngeal View during intubation. We will record according to the Cormack-Lehane Grade system.

Time Frame

10 min

Title

POGO score

Description

self-reported percentage of glottis opening (POGO) score

Time Frame

10 min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Emergency Medical Service

City

Poznan

Country

Poland

Facility Name

Emergency Medical Service

City

Warsaw

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

after manuscript publishing

Citations:

PubMed Identifier

35016094

Citation

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.

Results Reference

derived

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Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

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