A Different Use of The Aerosol Box in COVID-19 Patients; Internal Jugular Vein Cannulation
July 7, 2021 updated by: Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Use of Aerosol Box for Ultrasound-guided Internal Jugular Vein Cannulation in COVID-19 Patients; Single Center Experience
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
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
-
-
Bakirkoy
-
Istanbul, Bakirkoy, Turkey, 34147
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Group P
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 (PPE) or both of the aerosol box and PPE provide insertion of a central venous catheter in COVID-19 patients.
|
|
ACTIVE_COMPARATOR: Group P&A
The clinicians performed an internal jugular vein cannulation using personal protective equipment and aerosol box.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Questionnaire on the Use of Aerosol Boxes
Time Frame: 7 months from the index case of the pandemic in Turkey
|
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
|
|
Catheter-related infection after central venouse catheterization in COVID-19
Time Frame: 7 months from the index case of the pandemic in Turkey
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of arterial punctures
Time Frame: 7 months from the index case of the pandemic in Turkey
|
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
|
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)
March 20, 2020
Study Completion (ACTUAL)
September 30, 2020
Study Registration Dates
First Submitted
July 4, 2021
First Submitted That Met QC Criteria
July 7, 2021
First Posted (ACTUAL)
July 8, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 8, 2021
Last Update Submitted That Met QC Criteria
July 7, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-287
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.