Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

Sponsor

Lazarski University (Other)

Overall Status

Completed

CT.gov ID

NCT04365608

Collaborator

Poznan University of Medical Sciences (Other), Wroclaw Medical University (Other), Medical University of Bialystok (Other)

Enrollment

Locations

Arms

8.7

Actual Duration (Months)

Patients Per Site

5.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intubation Complication Intubation; Difficult or Failed Cardiac Arrest Influenza Safety Issues	Procedure: Direct laryngoscopy Procedure: Vie Scope laryngoscopy	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 20, 2020

Actual Primary Completion Date :

Nov 30, 2020

Actual Study Completion Date :

Dec 10, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Intubation success rate during at the first laryngoscopy [10 min]
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 [10 min]
Intubation difficulty assessed by Intubation difficulty Scale score
Complications related to tracheal intubation [10 min]
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 [10 min]
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 [10 min]
Duration of the interruption of chest compression during ETI procedure
Laryngeal View during intubation [10 min]
We will record the best laryngeal View during intubation. We will record according to the Cormack-Lehane Grade system.
POGO score [10 min]
self-reported percentage of glottis opening (POGO) score