Back to resultsA Different Use of The Aerosol Box in COVID-19 Patients; Internal Jugular Vein Cannulation
Primary Purpose
COVID-19 Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Internal jugular vein cannulation
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 Pneumonia focused on measuring Aerosol box, SARS-CoV-2 virus, COVID-19, Internal jugular vein, Personal protective equipment
Eligibility Criteria
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 İJV in evaluation with US
Sites / Locations
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group P
Group P&A
Arm Description
The clinicians performed an internal jugular vein cannulation using only personal protective equipment.
The clinicians performed an internal jugular vein cannulation using personal protective equipment and aerosol box.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Number of arterial punctures
The difference in the number of arterial punctures developed during central venous catheterization in patients with or without aerosol box.
Full Information
NCT ID
NCT04954118
First Posted
July 4, 2021
Last Updated
July 7, 2021
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04954118
Brief Title
A Different Use of The Aerosol Box in COVID-19 Patients; Internal Jugular Vein Cannulation
Official Title
Use of Aerosol Box for Ultrasound-guided Internal Jugular Vein Cannulation in COVID-19 Patients; Single Center Experience
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia
Keywords
Aerosol box, SARS-CoV-2 virus, COVID-19, Internal jugular vein, Personal protective equipment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group P
Arm Type
Active Comparator
Arm Description
The clinicians performed an internal jugular vein cannulation using only personal protective equipment.
Arm Title
Group P&A
Arm Type
Active Comparator
Arm Description
The clinicians performed an internal jugular vein cannulation using personal protective equipment and aerosol box.
Intervention Type
Procedure
Intervention Name(s)
Internal jugular vein cannulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Questionnaire on the Use of Aerosol Boxes
Description
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.
Time Frame
7 months from the index case of the pandemic in Turkey
Title
Catheter-related infection after central venouse catheterization in COVID-19
Description
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.
Time Frame
7 months from the index case of the pandemic in Turkey
Secondary Outcome Measure Information:
Title
Number of arterial punctures
Description
The difference in the number of arterial punctures developed during central venous catheterization in patients with or without aerosol box.
Time Frame
7 months from the index case of the pandemic in Turkey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 İJV in evaluation with US
Facility Information:
Facility Name
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
City
Istanbul
State/Province
Bakirkoy
ZIP/Postal Code
34147
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Different Use of The Aerosol Box in COVID-19 Patients; Internal Jugular Vein Cannulation
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