- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04447638
Percutaneous Tracheostomy With COVID-19
September 22, 2020 updated by: Mesut ERBAS, Çanakkale Onsekiz Mart University
Percutaneous Tracheostomy With Aerosol Box in COVID-19 Positive Patients in Intensive Care Unit: a Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
24
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
-
-
-
Canakkale, Turkey, 17020
- Canakkale Onsekiz Mart University
-
-
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
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Percutaneous tracheostomy performed with aerosol box in COVID-19 patients
Description
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
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: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complications observed in the cases in which we applied percutaneous tracheostomy with aerosol box
Time Frame: During the procedure
|
Complications
|
During the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 20, 2020
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
June 1, 2020
Study Registration Dates
First Submitted
June 24, 2020
First Submitted That Met QC Criteria
June 24, 2020
First Posted (Actual)
June 25, 2020
Study Record Updates
Last Update Posted (Actual)
September 24, 2020
Last Update Submitted That Met QC Criteria
September 22, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TT17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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