Central Venous Access ComplicationsCATH-RISKNCT07367620
Immediate Mechanical Complications After Central Venous Catheterization
An observational study of Central Venous Access Complications, run by Thomas Kander at 1 site in Sweden.
Trial summary
The goal of this observational study is to determine the incidence of immediate mechanical complications after central venous catheterization and to explore factors associated with major mechanical complications in adolescent and adult patients undergoing central venous catheter insertion in routine clinical care. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Central Venous Access Complications
- What is being tested?
- Central Venous Catheterization
- Type of treatment
- Medical device
- How many people
- 29,114 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2019to 17 Apr 2026
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients receiving a central venous catheter within the study period will be observed
Who may be able to join
- All patients receiving a central venous catheter within the study period will be observed
Who cannot join
- Patients who die within 24 hours for reasons unrelated to the catheterization will be excluded, whereas patients whose death is directly related to the central venous catheterization will be included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Mechanical Complications After Central Venous Catheterization; a Multicentre Cohort Study
The goal of this observational study is to determine the incidence of immediate mechanical complications after central venous catheterization and to explore factors associated with major mechanical complications in adolescent and adult patients undergoing central venous catheter insertion in routine clinical care.
The main questions it aims to answer are:
Read more
What is the incidence of immediate mechanical complications, including major complications, following central venous catheterization?
Which patient-, operator-, and procedure-related factors are associated with major mechanical complications?
To what extent can these factors be combined to estimate the risk of major mechanical complications before catheter insertion?
This study builds on a previous multicentre registry study of central venous catheterization but includes a substantially larger number of catheter insertions. An additional exploratory objective is to assess the feasibility of developing a risk estimation model (CATH-RISK) for major mechanical complications based on available data.
Participants will have their central venous catheter insertions and related clinical data recorded in an existing clinical registry. No interventions beyond standard clinical care will be performed.
Read the detailed description
Central venous catheterization is a common invasive procedure in anaesthesia, intensive care, and emergency medicine, but it is associated with a risk of immediate mechanical complications ranging from minor events to rare but potentially life-threatening major complications. Although the widespread use of real-time ultrasound guidance has reduced complication rates, major mechanical complications continue to occur and remain clinically important.
This observational registry study (CATH-RISK) is designed to extend a previously conducted multicentre cohort study of mechanical complications after central venous catheterization by substantially increasing the number of included catheter insertions. The larger dataset will allow more precise estimation of complication rates and more robust assessment of factors associated with major mechanical complications occurring in close temporal relation to catheter insertion.
All central venous catheter insertions performed in participating hospitals during the study period will be identified through existing electronic health record-based registries. Mechanical complications occurring within a predefined time window after catheter insertion will be systematically recorded and classified according to predefined criteria. Patient-related, operator-related, and procedure-related variables routinely available in clinical documentation will be extracted for analysis.
The primary objective of the study is to determine the incidence of immediate mechanical complications, including major mechanical complications, after central venous catheterization in contemporary clinical practice. Secondary objectives include identifying factors associated with major mechanical complications and describing their relative contributions.
An additional exploratory objective is to assess the feasibility of combining selected variables into a risk estimation model (CATH-RISK) for major mechanical complications. Given the expected low incidence of major complications, any modelling will be considered hypothesis-generating and aimed at evaluating potential clinical usefulness rather than establishing a definitive prediction tool.
The study is purely observational and does not involve any deviation from standard clinical care. No study-specific interventions will be performed, and no additional procedures, examinations, or follow-up visits will be required for participants.
- Conditions
- Central Venous Access Complications
- Being tested
- Central Venous Catheterization
- Keywords
- central venous catheters, Catheterization, Central Venous, Vascular Access Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Venous CatheterizationDevice
No intervention is assigned in this study. Central venous catheter insertions are performed according to standard clinical practice and local guidelines at participating hospitals. The study involves observational data collection only, using information routinely documented in the electronic health record and clinical registries. No changes to patient management, catheterization technique, or follow-up are introduced as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing central venous catheterization | This cohort includes adolescent and adult patients undergoing central venous catheter insertion as part of routine clinical care at participating hospitals. Catheterizations are performed according to local clinical guidelines and standard practice, predominantly using real-time ultrasound guidance. No study-specific interventions are mandated.
Data on patient characteristics, operator factors, procedural details, and immediate mechanical complications occurring after catheter insertion are collected from existing electronic health record-based registries. The study is purely observational and does not influence clinical decision-making, choice of catheterization technique, or patient management. Receives: Device: Central Venous Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases with bleeding grade 3-4
Mechanical complication after CVC-insertion. Grade 3 bleedings/hematoma formation/hemothorax (bleedings requiring invasive intervention or blood transfusion) or arterial catheter placement and grade 4 bleedings/hemothorax (life-threatening bleedings). All grade 3-4 bleedings will be classified as major mechanical complications.
Measured: Up to 24 hours after insertion of the central venous catheter
Number of cases with arrhythmia grad 3-4 during the inserting procedure
Mechanical complication during the CVC-insertion. Recognized at the continuous ECG by the inserting physician or the assistant. Arrhythmias grade 3 (symptomatic arrhythmia requiring urgent medical intervention) and grade 4 (symptomatic arrhythmia with life-threatening consequences) will be considered major mechanical complications.
Measured: During the procedure of inserting the central venous catheter
Number of cases with pneumothorax at post-procedural x-ray of the thorax
Mechanical complication after CVC-insertion. Pneumothoraces will be detected using x-ray after the central venous catheter insertion. All pneumothoraces will be classified as major mechanical complications
Measured: Up to 24 hours after insertion of the central venous catheter
Number of cases with persistent nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function
Mechanical complication after CVC-insertion. Will be detected and documented by the patient responsible physician or nurse. Will be considered a major mechanical complication.
Measured: Persistent more than 72 hours after insertion of the central venous catheter
Secondary outcomes (4)
Number of cases with failure to place the catheter
An attempt to insert a central venous catheter was performed but failed. Will be detected by the inserting anesthesiologist. Will be classified as minor mechanical complications.
Measured: During the procedure of inserting the central venous catheter
Number of cases with bleeding grad 2
Mechanical complication after CVC-insertion. Grade 2 bleedings/hematoma formation (bleedings requiring external compression) or arterial puncture with the steel canula. Will be detected during the inserting procedure or at the daily inspection by the patient responsible physician or nurse. Will be considered minor mechanical complications.
Measured: Up to 24 hours after insertion of the central venous catheter
Number of cases with arrhythmia grad 1-2 during the inserting procedure
Mechanical complication during the CVC-insertion. Recognized at the continuous ECG by the inserting physician or the assistant. Arrhythmias grade 1 (asymptomatic arrhythmia not requiring intervention) and grade 2 (asymptomatic or symptomatic arrhythmia requiring non-urgent medical intervention) will be considered minor mechanical complications.
Measured: During the procedure of inserting the central venous catheter
Number of cases with transient nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function
Mechanical complication after CVC-insertion. Will be detected and documented by the patient responsible nurse. Will be considered a minor mechanical complication.
Measured: Transient up to 72 hours after insertion of the central venous catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Mar 2019
- Primary completion16 Aug 2025
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous Access ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 29,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Kander
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane, Lund University
- Responsible party
- Sponsor-investigator, Thomas Kander, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367620
- Sponsor's protocol ID
- CATH-RISK
- Acronym
- CATH-RISK
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected in this study will not be made publicly available. De-identified data may be shared with qualified researchers upon reasonable request, subject to approval by the study steering committee and applicable ethical and legal regulations. Requests should include a methodologically sound research proposal and may require a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Mechanical Complications After Central Venous Catheterization; a Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT07367620
- Acronym / sponsor ID
- CATH-RISK / CATH-RISK
- Conditions
- Central Venous Access Complications
- Keywords
- central venous catheters, Catheterization, Central Venous, Vascular Access Devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29,114 participants (actual)
- Lead sponsor
- Thomas KanderUniversity, hospital or other
- Collaborators
- Region Skane, Lund University
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 16 Aug 2025 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 26 Jan 2026 (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 goal of this observational study is to determine the incidence of immediate mechanical complications after central venous catheterization and to explore factors associated with major mechanical complications in adolescent and adult patients undergoing central venous catheter insertion in routine clinical care.
The main questions it aims to answer are:
What is the incidence of immediate mechanical complications, including major complications, following central venous catheterization?
Which patient-, operator-, and procedure-related factors are associated with major mechanical complications?
To what extent can these factors be combined to estimate the risk of major mechanical complications before catheter insertion?
This study builds on a previous multicentre registry study of central venous catheterization but includes a substantially larger number of catheter insertions. An additional exploratory objective is to assess the feasibility of developing a risk estimation model (CATH-RISK) for major mechanical complications based on available data.
Participants will have their central venous catheter insertions and related clinical data recorded in an existing clinical registry. No interventions beyond standard clinical care will be performed.
Detailed description
Central venous catheterization is a common invasive procedure in anaesthesia, intensive care, and emergency medicine, but it is associated with a risk of immediate mechanical complications ranging from minor events to rare but potentially life-threatening major complications. Although the widespread use of real-time ultrasound guidance has reduced complication rates, major mechanical complications continue to occur and remain clinically important.
This observational registry study (CATH-RISK) is designed to extend a previously conducted multicentre cohort study of mechanical complications after central venous catheterization by substantially increasing the number of included catheter insertions. The larger dataset will allow more precise estimation of complication rates and more robust assessment of factors associated with major mechanical complications occurring in close temporal relation to catheter insertion.
All central venous catheter insertions performed in participating hospitals during the study period will be identified through existing electronic health record-based registries. Mechanical complications occurring within a predefined time window after catheter insertion will be systematically recorded and classified according to predefined criteria. Patient-related, operator-related, and procedure-related variables routinely available in clinical documentation will be extracted for analysis.
The primary objective of the study is to determine the incidence of immediate mechanical complications, including major mechanical complications, after central venous catheterization in contemporary clinical practice. Secondary objectives include identifying factors associated with major mechanical complications and describing their relative contributions.
An additional exploratory objective is to assess the feasibility of combining selected variables into a risk estimation model (CATH-RISK) for major mechanical complications. Given the expected low incidence of major complications, any modelling will be considered hypothesis-generating and aimed at evaluating potential clinical usefulness rather than establishing a definitive prediction tool.
The study is purely observational and does not involve any deviation from standard clinical care. No study-specific interventions will be performed, and no additional procedures, examinations, or follow-up visits will be required for participants.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing central venous catheterization | – | Device: Central Venous CatheterizationThis cohort includes adolescent and adult patients undergoing central venous catheter insertion as part of routine clinical care at participating hospitals. Catheterizations are performed according to local clinical guidelines and standard practice, predominantly using real-time ultrasound guidance. No study-specific interventions are mandated. Data on patient characteristics, operator factors, procedural details, and immediate mechanical complications occurring after catheter insertion are collected from existing electronic health record-based registries. The study is purely observational and does not influence clinical decision-making, choice of catheterization technique, or patient management. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving a central venous catheter within the study period will be observed
Key inclusion criteria (1 listed)
- All patients receiving a central venous catheter within the study period will be observed
Key exclusion criteria (1 listed)
- Patients who die within 24 hours for reasons unrelated to the catheterization will be excluded, whereas patients whose death is directly related to the central venous catheterization will be included
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 |
|---|---|---|
| Central Venous CatheterizationNo intervention is assigned in this study. Central venous catheter insertions are performed according to standard clinical practice and local guidelines at participating hospitals. The study involves observational data collection only, using information routinely documented in the electronic health record and clinical registries. No changes to patient management, catheterization technique, or follow-up are introduced as part of the study. | Device | Patients undergoing central venous catheterization |
Primary outcome
Number of cases with bleeding grade 3-4
Time frame: Up to 24 hours after insertion of the central venous catheter
Mechanical complication after CVC-insertion. Grade 3 bleedings/hematoma formation/hemothorax (bleedings requiring invasive intervention or blood transfusion) or arterial catheter placement and grade 4 bleedings/hemothorax (life-threatening bleedings). All grade 3-4 bleedings will be classified as major mechanical complications.
Number of cases with arrhythmia grad 3-4 during the inserting procedure
Time frame: During the procedure of inserting the central venous catheter
Mechanical complication during the CVC-insertion. Recognized at the continuous ECG by the inserting physician or the assistant. Arrhythmias grade 3 (symptomatic arrhythmia requiring urgent medical intervention) and grade 4 (symptomatic arrhythmia with life-threatening consequences) will be considered major mechanical complications.
Number of cases with pneumothorax at post-procedural x-ray of the thorax
Time frame: Up to 24 hours after insertion of the central venous catheter
Mechanical complication after CVC-insertion. Pneumothoraces will be detected using x-ray after the central venous catheter insertion. All pneumothoraces will be classified as major mechanical complications
Number of cases with persistent nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function
Time frame: Persistent more than 72 hours after insertion of the central venous catheter
Mechanical complication after CVC-insertion. Will be detected and documented by the patient responsible physician or nurse. Will be considered a major mechanical complication.
4 secondary outcomes
Number of cases with failure to place the catheter
Time frame: During the procedure of inserting the central venous catheter
Number of cases with bleeding grad 2
Time frame: Up to 24 hours after insertion of the central venous catheter
Number of cases with arrhythmia grad 1-2 during the inserting procedure
Time frame: During the procedure of inserting the central venous catheter
Number of cases with transient nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function
Time frame: Transient up to 72 hours after insertion of the central venous catheter
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 28 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data collected in this study will not be made publicly available. De-identified data may be shared with qualified researchers upon reasonable request, subject to approval by the study steering committee and applicable ethical and legal regulations. Requests should include a methodologically sound research proposal and may require a data use agreement.
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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?
An observational study of Central Venous Access Complications, run by Thomas Kander at 1 site in Sweden.
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 28 Apr 2026. 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 Sweden. 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?
Number of cases with bleeding grade 3-4 (time frame: Up to 24 hours after insertion of the central venous catheter). The study lists 4 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 28 Apr 2026.