COVID-19 PneumoniaNCT04954118
A Different Use of The Aerosol Box in COVID-19 Patients; Internal Jugular Vein Cannulation
A study testing Internal jugular vein cannulation in people with COVID-19 Pneumonia, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- Internal jugular vein cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with COVID-19 and inserted central venous catheter while being treated in the ward
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Bakirkoy, 34147
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19 Pneumonia
- Being tested
- Internal jugular vein cannulation
- Keywords
- Aerosol box, SARS-CoV-2 virus, COVID-19, Internal jugular vein, Personal protective equipment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal jugular vein cannulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | The clinicians performed an internal jugular vein cannulation using only personal protective equipment. Receives: Procedure: Internal jugular vein cannulation |
| Group P&A | Active comparator | The clinicians performed an internal jugular vein cannulation using personal protective equipment and aerosol box. Receives: Procedure: Internal jugular vein cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months from the index case of the pandemic in Turkey
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.
Measured: 7 months from the index case of the pandemic in Turkey
Secondary outcomes (1)
Number of arterial punctures
The difference in the number of arterial punctures developed during central venous catheterization in patients with or without aerosol box.
Measured: 7 months from the index case of the pandemic in Turkey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start20 Mar 2020
- Primary completion20 Mar 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954118
- Sponsor's protocol ID
- 2020-287
- Status last verified
- Jul 2021
- First submitted
- 4 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Aerosol Box for Ultrasound-guided Internal Jugular Vein Cannulation in COVID-19 Patients; Single Center Experience
- ClinicalTrials.gov ID
- NCT04954118
- Acronym / sponsor ID
- 2020-287
- Conditions
- COVID-19 Pneumonia
- Keywords
- Aerosol box, SARS-CoV-2 virus, COVID-19, Internal jugular vein, Personal protective equipment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Procedure: Internal jugular vein cannulationThe clinicians performed an internal jugular vein cannulation using only personal protective equipment. |
| Group P&A | Active comparator | Procedure: Internal jugular vein cannulationThe clinicians performed an internal jugular vein cannulation using personal protective equipment and aerosol box. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with COVID-19 and inserted central venous catheter while being treated in the ward
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internal jugular vein cannulationThe 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. | Procedure or surgery | Group P, Group P&A |
Primary outcome
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.
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.
1 secondary outcome
Number of arterial punctures
Time frame: 7 months from the index case of the pandemic in Turkey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal jugular vein cannulation in people with COVID-19 Pneumonia, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire on the Use of Aerosol Boxes (time frame: 7 months from the index case of the pandemic in Turkey). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.