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Percutaneous Tracheostomy With COVID-19

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ClinicalTrials.gov Identifier: NCT04447638
Recruitment Status : Completed
First Posted : June 25, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Mesut ERBAS, Çanakkale Onsekiz Mart University

Brief Summary:
Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation.

Condition or disease Intervention/treatment
Tracheostomy Procedure: Tracheostomy with aerosol box in COVID-19 positive patients

Detailed Description:
Different methods are needed for situations in which the potential for producing aerosols is high, such as intubation and tracheostomy. One of these methods is the aerosol box.To share our experiences of percutaneous tracheostomy performed with aerosol box in COVID-19 patients. Patients who underwent percutaneous tracheostomy between March 2020 and June 2020 in the pandemic intensive care unit were evaluated retrospectively.The study is designed as a clinical trial study. This study was performed in faculty of medicine hospital's intensive care unit which is located in Canakkale province Turkey.

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Percutaneous Tracheostomy With Aerosol Box in COVID-19 Positive Patients in Intensive Care Unit: a Clinical Trial
Actual Study Start Date : March 20, 2020
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : June 1, 2020

Intervention Details:
  • Procedure: Tracheostomy with aerosol box in COVID-19 positive patients
    Patients who underwent percutaneous tracheostomy with aerosol box in COVID-19 positive patients. The patients age, gender, hospitalization diagnosis, number of intubated days, anesthetic agents used during the procedure, neck ultrasonography data before and during the procedure, and complications were recorded.


Primary Outcome Measures :
  1. Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box [ Time Frame: During the procedure ]
    Complications



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Percutaneous tracheostomy performed with aerosol box in COVID-19 patients
Criteria

Inclusion Criteria:

  • who underwent percutaneous tracheostomy with COVID-19(+)

Exclusion Criteria:

  • Patients who do not give informed consent or do not want to participate in the study
  • Coagulopathy, thrombocytopenia

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): NCT04447638


Locations
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Turkey
Canakkale Onsekiz Mart University
Canakkale, Turkey, 17020
Sponsors and Collaborators
Çanakkale Onsekiz Mart University
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Responsible Party: Mesut ERBAS, Associate Professor, Çanakkale Onsekiz Mart University
ClinicalTrials.gov Identifier: NCT04447638    
Other Study ID Numbers: TT17
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Mesut ERBAS, Çanakkale Onsekiz Mart University:
Reanimation