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Percutaneous Tracheostomy With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 24, 2020
First Posted Date June 25, 2020
Last Update Posted Date September 24, 2020
Actual Study Start Date March 20, 2020
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2020)
Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box [ Time Frame: During the procedure ]
Complications
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Percutaneous Tracheostomy With COVID-19
Official Title Percutaneous Tracheostomy With Aerosol Box in COVID-19 Positive Patients in Intensive Care Unit: a Clinical Trial
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Percutaneous tracheostomy performed with aerosol box in COVID-19 patients
Condition Tracheostomy
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 22, 2020)
24
Original Actual Enrollment
 (submitted: June 24, 2020)
12
Actual Study Completion Date June 1, 2020
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04447638
Other Study ID Numbers TT17
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Mesut ERBAS, Çanakkale Onsekiz Mart University
Study Sponsor Çanakkale Onsekiz Mart University
Collaborators Not Provided
Investigators Not Provided
PRS Account Çanakkale Onsekiz Mart University
Verification Date September 2020