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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04954118
Other study ID # 2020-287
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2020
Est. completion date September 30, 2020

Study information

Verified date July 2021
Source Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During the COVID-19 pandemic, health employees are at high risk of infection. This study aimed to determine experiences with an aerosol box (AB), used with the aim of preventing contamination by droplets during internal jugular vein cannulation which requires close contact with COVID-19 patients, and the necessity to use this device.


Description:

The study included 40 patients with diagnosis of COVID-19 requiring central venous catheter during treatment in the ward. The patients were randomly allocated to one of the two protective equipment groups and, then, randomly assigned to one of the five clinicians. Group P&A had both personal protective equipment (PPE) and AB used, while Group P included patients where PPE was used alone. Clinicians completed a survey after performing the procedure to evaluate the use of the aerosol box. Collected data of the procedures and patients, were analyzed. In addition, survey data were evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 30, 2020
Est. primary completion date March 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients diagnosed with COVID-19 and inserted central venous catheter while being treated in the ward Exclusion Criteria: - Patients under the age of 18 years - Patients who can not lie in the supine position due to severe respiratory distress, - Patients with thrombus in the right IJV in evaluation with US

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Internal jugular vein cannulation
The clinicians performed an internal jugular vein cannulation using personal protective equipment (PPE) or both of the aerosol box and PPE provide insertion of a central venous catheter in COVID-19 patients.

Locations

Country Name City State
Turkey Bakirkoy Dr. Sadi Konuk Research and Training Hospital Istanbul Bakirkoy

Sponsors (1)

Lead Sponsor Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaire on the Use of Aerosol Boxes There is no valid and reliable questionnaire in the literature that evaluates behaviors and attitudes towards aerosol box use. Therefore, in our study, a questionnaire was conducted about the attitudes and behaviors of the participants towards aerosol box preservatives.There are 6 statements in the content of the questionnaire on aerosol box use. The questionnaire consists of expressions such as "1-Discomfort using box, 2-Difficulty in manipulation during the performance, 3-Difficulty in use of US device restricted by box, 4-Increased cognitive load from use of box, 5-Increased physical load from use of box, 6-User satisfaction respectively. Participants were asked to answer these statements as ''yes or no''. According to the response received, positive or negative attitudes towards the use of aerosol boxes were evaluated. 7 months from the index case of the pandemic in Turkey
Primary Catheter-related infection after central venouse catheterization in COVID-19 When the body temperature of the patients is above 38, blood, urine and if the patient is intubated, a tracheal aspirate culture will be taken.
If the blood culture test is a positive, a diagnosis of catheter-related infection will be made and central venouse catheter will be removed.
7 months from the index case of the pandemic in Turkey
Secondary Number of arterial punctures The difference in the number of arterial punctures developed during central venous catheterization in patients with or without aerosol box. 7 months from the index case of the pandemic in Turkey
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