Effect of Using Barrier Devices for Intubation in COVID-19 Patients

Completed

• Conditions: Intubation, Intratracheal; COVID-19

• Registration Number: NCT04412226
• Lead Sponsor: Derince Training and Research Hospital

Brief Summary

The aim of this study is to compare the impact of using the aerosol box and transparent sheet as an adjunct to conventional personal protective equipment on endotracheal intubation of COVID-19 patients. The effect of the head of the bed elevation will also be evaluated during the mentioned simulated scenarios.

Detailed Description

This is a randomized, prospective, manikin simulation study. Emergency medicine specialists will be participated in the study. Participants will be randomly assigned into 6 groups with a 1:1:1:1:1:1 allocation following simple randomization procedures by a program generating online random numbers. 13 participants will be recruited to the study.

Operators who will intubate the manikin will use following methods: (1) conventional personal protective equipment (PPE) with placing the manikin in the supine position. (2) aerosol box as an adjunct to PPE with placing the manikin in the supine position. (3) transparent sheet as an adjunct to PPE with placing the manikin in the supine position. (4) conventional personal protective equipment (PPE) with placing the manikin in the 30 degree the head of the bed elevated position. (5) aerosol box as an adjunct to PPE with placing the manikin in the 30 degree the head of the bed elevated position. (6) transparent sheet as an adjunct to PPE with placing the manikin in the 30 degree the head of the bed elevated position.

Study Timeline

• Study First Submitted: 2020-05-31
• Study First Submitted QC: 2020-05-31
• Study First Posted: 2020-06-02
• Study Start: 2020-06-10
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Participants who want to participate the study

Exclusion Criteria

• Participants who do not want to participate the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First pass success	2 minutes	Comparison of the first pass success rates for each method that were mentioned in the 'Detailed Description' of the study.

Secondary Outcome Measures

Name	Time	Method
Difficulty level of inserting the endotracheal tube into the glottis	2 minutes	Grading the difficulty of inserting the endotracheal tube into the glottis on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.
Difficulty level of accessing the equipment	2 minutes	Grading the difficulty of accessing the equipment on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.
Time to endotracheal intubation	2 minutes	The mean time to successful endotracheal intubation for each method that were mentioned in the 'Detailed Description' of the study.
Clarity of the view of the patient's face	2 minutes	Grading the clarity of the view of the patient's face on a 5-point Likert scale for each method that were mentioned in the 'Detailed Description' of the study.

Trial Locations

Locations (1)

Kocaeli Derince Training and Research Hospital; 🇹🇷 Kocaeli, Izmit, Turkey