Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365608
• Other study ID #: INT_EMS_PPE_1
• Status: Completed
• Phase: N/A
• Start date: March 20, 2020
• Est. completion date: December 10, 2020

Study information

• Verified date: December 2020
• Source: Lazarski University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 10, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Direct laryngoscopy
standard laryngoscope with Macintosh blade
• Vie Scope laryngoscopy
Vie Scope with dedicated bougie stylet

Locations

Country	Name	City	State
Poland	Emergency Medical Service	Poznan
Poland	Emergency Medical Service	Warsaw

Sponsors (4)

Lead Sponsor	Collaborator
Lazarski University	Medical University of Bialystok, Poznan University of Medical Sciences, Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intubation difficulty Scale score	Intubation difficulty assessed by Intubation difficulty Scale score	10 min
Secondary	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
Secondary	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
Secondary	Duration of the interruption of chest compression during ETI procedure	Duration of the interruption of chest compression during ETI procedure	10 min
Secondary	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
Secondary	POGO score	self-reported percentage of glottis opening (POGO) score	10 min