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Completed

NCT Number: NCT04412226

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

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.

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Key information

Conditions

Intubation, Intratracheal COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli Derince Training and Research Hospital

Kocaeli, Izmit, 41900, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who want to participate the study

Exclusion criteria

  • Participants who do not want to participate the study

Treatment and study plan

Aerosol box

Device

The aerosol box is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cube that covers the patient's head during the endotracheal intubation. Operator can intubate the patient through the two holes for arms.

transparent sheet

Device

The transparent sheet is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cover that covers the patient's head and body during the endotracheal intubation. Operator can intubate the patient through the space under the cover

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Derince Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2020
Registry last updated
Dec 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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