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

December 2, 2020 updated by: ASIM ENES ÖZBEK, Derince Training and Research Hospital

Effect of Using Barrier Devices for Intubation in COVID-19 Patients: Randomized, Prospective, Manikin Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Izmit
      • Kocaeli, Izmit, Turkey, 41900
        • Kocaeli Derince Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population includes emergency medicine specialists who wants to participate to the study.

Description

Inclusion Criteria:

  • Participants who want to participate the study

Exclusion Criteria:

  • Participants who do not want to participate the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First pass success
Time Frame: 2 minutes
Comparison of the first pass success rates for each method that were mentioned in the 'Detailed Description' of the study.
2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to endotracheal intubation
Time Frame: 2 minutes
The mean time to successful endotracheal intubation for each method that were mentioned in the 'Detailed Description' of the study.
2 minutes
Difficulty level of accessing the equipment
Time Frame: 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.
2 minutes
Difficulty level of inserting the endotracheal tube into the glottis
Time Frame: 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.
2 minutes
Clarity of the view of the patient's face
Time Frame: 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.
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derince Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

May 31, 2020

First Submitted That Met QC Criteria

May 31, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

December 4, 2020

Last Update Submitted That Met QC Criteria

December 2, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/56

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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