SARS-CoV-2 ICU BoundNCT04992221
Arterial Line Patency in ICU Bound COVID-19 Patients
An observational study of SARS-CoV-2 ICU Bound, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
The health care system was completely overwhelmed by the SARS-Cov-2 virus, and ICU admissions soared as a result of the ICU doctors' increased workload. A committed crew inserts invasive line procedures to guarantee a secure and efficient performance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV-2 ICU Bound
- What is being tested?
- arterial line
- Type of treatment
- Surgery or procedure
- How many people
- 245 participants
- Where
- 1 siteQatar
- Study dates
- 1 Feb 2021to 1 Apr 2022
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive ICU patients at HMGH Hospital; Hamad Medical Corporation with continuous invasive monitoring will be enrolled if they met following eligibility criteria: peripheral artery cannulation with a suitable arterial cannula and a functional arterial line established after insertion.
Who may be able to join
- Consecutive ICU patients at HMGH Hospital; Hamad Medical Corporation with continuous invasive monitoring will be enrolled if they met following eligibility criteria: peripheral artery cannulation with a suitable arterial cannula and a functional arterial line established after insertion.
Who cannot join
- Other pateints with COVID-19 NOT ICU bound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors Affected the Duration of Arterial Line Patency in ICU Bound COVID-19 Patients
The health care system was completely overwhelmed by the SARS-Cov-2 virus, and ICU admissions soared as a result of the ICU doctors' increased workload. A committed crew inserts invasive line procedures to guarantee a secure and efficient performance. When COVID-19 bound patients were followed up on in the second wave, frequent requests for arterial line placement were noted. These critically ill individuals had high rates of thrombosis, which was linked to thrombotic consequences. Many factors, such as patient morbidities, insertion technique, and operational health care trained personnel's qualifications, contribute to the lowering of arterial line patency.
Our ICU management committee approved the use of systemic anticoagulation of ICU admitted patients starting on March 21, 2021 in response to an increase in the incidence of thrombosis and pulmonary embolic events in patients with COVID-19 admitted to the ICU in the second wave of the epidemic.
Read the detailed description
- Introduction / Background The number of Coronavirus Disease 2019 (COVID-19) patients admitted to the intensive care unit has increased, and it has been noted that this pandemic is linked to high rates of thrombosis, which has exacerbated its effects on those critically ill patients.
In order to provide a multidisciplinary, safe service for invasive vascular procedures, as well as endotracheal intubations and the rapid response team (RRT) for quick assessment of deteriorating patients in the ward who were in need of ICU admission, which was reported before at a USA institute, we established a dedicated invasive procedure team from anesthetists during the peak admission of patients with COVID-19 to the ICU.
Invasive vascular access was employed for hemodynamic monitoring and management in patients undergoing high-risk surgery, especially in patients who were admitted to the intensive care unit.Different techniques, such as the use of heparinized fluids, are utilized to lower the incidence of arterial line failure.
Their main goal was to extend the average patency time of 5 to 10 days. When the arterial line was implanted for more than 2-3 days, the occlusion was documented. One frequent consequence is a transient arterial blockage.
We observed an upsurge in demand for arterial line insertions either in newly admitted or existing ICU patients during the COVID crisis. In addition to posing challenges for the ICU staff member, the repeated insertion of arterial lines raises the patient's risk for ischemia thrombosis and infectious occurrences in their limbs. However, there aren't many publications on the risk factors for arterial line blockages in ICU patients with COVID-19.
Our ICU management committee approved the use of systemic anticoagulation of ICU admitted patients starting on March 21, 2021 in response to an increase in the incidence of thrombosis and pulmonary embolic events in patients with COVID-19 admitted to the ICU in the second wave of this epidemic.
This observational study compares patients before and after the implementation of systemic anti coagulation to examine the effects of the medication on arterial line patency and the incidence of arterial line failure.
Identifying risk factors for impaired arterial line patency in both groups will be the secondary outcome.
- Conditions
- SARS-CoV-2 ICU Bound
- Being tested
- arterial line
- Keywords
- SARS-CoV-2, arterial line patency, Risk factors, ICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arterial lineProcedure or surgery
arterial line inserted for invasice mointroing and sampling
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of arterial line failure in ICU bound COVID-19 patients
Measured: 60-90 days
Secondary outcomes (1)
Risk factors affecting the arterial line patency
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Feb 2021
- Primary completion31 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 ICU BoundStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992221
- Sponsor's protocol ID
- MRC-01-21-492
- Status last verified
- Feb 2021
- First submitted
- 4 Aug 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Affected the Duration of Arterial Line Patency in ICU Bound COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04992221
- Acronym / sponsor ID
- MRC-01-21-492
- Conditions
- SARS-CoV-2 ICU Bound
- Keywords
- SARS-CoV-2, arterial line patency, Risk factors, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 5 Aug 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.
The health care system was completely overwhelmed by the SARS-Cov-2 virus, and ICU admissions soared as a result of the ICU doctors' increased workload. A committed crew inserts invasive line procedures to guarantee a secure and efficient performance. When COVID-19 bound patients were followed up on in the second wave, frequent requests for arterial line placement were noted. These critically ill individuals had high rates of thrombosis, which was linked to thrombotic consequences. Many factors, such as patient morbidities, insertion technique, and operational health care trained personnel's qualifications, contribute to the lowering of arterial line patency.
Our ICU management committee approved the use of systemic anticoagulation of ICU admitted patients starting on March 21, 2021 in response to an increase in the incidence of thrombosis and pulmonary embolic events in patients with COVID-19 admitted to the ICU in the second wave of the epidemic.
Detailed description
- Introduction / Background The number of Coronavirus Disease 2019 (COVID-19) patients admitted to the intensive care unit has increased, and it has been noted that this pandemic is linked to high rates of thrombosis, which has exacerbated its effects on those critically ill patients.
In order to provide a multidisciplinary, safe service for invasive vascular procedures, as well as endotracheal intubations and the rapid response team (RRT) for quick assessment of deteriorating patients in the ward who were in need of ICU admission, which was reported before at a USA institute, we established a dedicated invasive procedure team from anesthetists during the peak admission of patients with COVID-19 to the ICU.
Invasive vascular access was employed for hemodynamic monitoring and management in patients undergoing high-risk surgery, especially in patients who were admitted to the intensive care unit.Different techniques, such as the use of heparinized fluids, are utilized to lower the incidence of arterial line failure.
Their main goal was to extend the average patency time of 5 to 10 days. When the arterial line was implanted for more than 2-3 days, the occlusion was documented. One frequent consequence is a transient arterial blockage.
We observed an upsurge in demand for arterial line insertions either in newly admitted or existing ICU patients during the COVID crisis. In addition to posing challenges for the ICU staff member, the repeated insertion of arterial lines raises the patient's risk for ischemia thrombosis and infectious occurrences in their limbs. However, there aren't many publications on the risk factors for arterial line blockages in ICU patients with COVID-19.
Our ICU management committee approved the use of systemic anticoagulation of ICU admitted patients starting on March 21, 2021 in response to an increase in the incidence of thrombosis and pulmonary embolic events in patients with COVID-19 admitted to the ICU in the second wave of this epidemic.
This observational study compares patients before and after the implementation of systemic anti coagulation to examine the effects of the medication on arterial line patency and the incidence of arterial line failure.
Identifying risk factors for impaired arterial line patency in both groups will be the secondary outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive ICU patients at HMGH Hospital; Hamad Medical Corporation with continuous invasive monitoring will be enrolled if they met following eligibility criteria: peripheral artery cannulation with a suitable arterial cannula and a functional arterial line established after insertion.
Key inclusion criteria (1 listed)
- Consecutive ICU patients at HMGH Hospital; Hamad Medical Corporation with continuous invasive monitoring will be enrolled if they met following eligibility criteria: peripheral artery cannulation with a suitable arterial cannula and a functional arterial line established after insertion.
Key exclusion criteria (1 listed)
- Other pateints with COVID-19 NOT ICU bound
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 |
|---|---|---|
| arterial linearterial line inserted for invasice mointroing and sampling | Procedure or surgery | – |
Primary outcome
Incidence of arterial line failure in ICU bound COVID-19 patients
Time frame: 60-90 days
1 secondary outcome
Risk factors affecting the arterial line patency
Time frame: 6 months
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 14 Nov 2022.
- Individual participant dataSharing planned: No
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?
An observational study of SARS-CoV-2 ICU Bound, run by Hamad Medical Corporation at 1 site in Qatar.
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 1 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 14 Nov 2022. 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 Qatar. 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?
Incidence of arterial line failure in ICU bound COVID-19 patients (time frame: 60-90 days). 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 14 Nov 2022.