Prehospital Intubation of COVID-19 Patient With Personal Protective Equipment

Not Applicable

Completed

• Conditions: Intubation Complication; Cardiac Arrest; Safety Issues; Intubation; Difficult or Failed; Influenza
• Interventions: Procedure: Direct laryngoscopy; Procedure: Vie Scope laryngoscopy

• Registration Number: NCT04365608
• Lead Sponsor: Lazarski University

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

Study Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-28
• Primary Completion: 2020-11-30
• Status Verified: 2020-12
• Study Completion: 2020-12-10
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct laryngoscopy	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.
Vie Scope laryngoscopy	Vie Scope laryngoscopy	Intubation will be done using Vie Scope laryngoscopy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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.
Duration of the interruption of chest compression during ETI procedure	10 min	Duration of the interruption of chest compression during ETI procedure
POGO score	10 min	self-reported percentage of glottis opening (POGO) score

Trial Locations

Locations (1)

Emergency Medical Service; 🇵🇱 Warsaw, Poland