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

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ClinicalTrials.gov Identifier: NCT04412226
Recruitment Status : Completed
First Posted : June 2, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
ASIM ENES ÖZBEK, 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.

Condition or disease Intervention/treatment
Intubation, Intratracheal COVID-19 Device: aerosol box Device: transparent sheet

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.

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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effect of Using Barrier Devices for Intubation in COVID-19 Patients: Randomized, Prospective, Manikin Study
Actual Study Start Date : June 10, 2020
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Intervention Details:
  • Device: aerosol box
    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.
  • Device: transparent sheet
    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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population includes emergency medicine specialists who wants to participate to the study.
Criteria

Inclusion Criteria:

  • Participants who want to participate the study

Exclusion Criteria:

  • Participants who do not want to participate the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412226


Locations
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Turkey
Kocaeli Derince Training and Research Hospital
Kocaeli, Izmit, Turkey, 41900
Sponsors and Collaborators
Derince Training and Research Hospital
Additional Information:
Publications:
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Responsible Party: ASIM ENES ÖZBEK, Principal Investigator, Derince Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04412226    
Other Study ID Numbers: 2020/56
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ASIM ENES ÖZBEK, Derince Training and Research Hospital:
aerosol box
COVID-19
intubation
personal protective equipment
barrier device