Mechanical Complications of Central Venous CatheterCVC-MECHNCT03782324
Mechanical Complications After Central Venous Catheterisation
An observational study of Mechanical Complications of Central Venous Catheter, run by Region Skane at 1 site in Sweden.
Trial summary
Central venous catheters are common in modern health care and are being increasingly used in both intensive care units and general wards. The primary aim of this study is to determine the incidence of mechanical complications within 24 hours after central venous catheterisation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mechanical Complications of Central Venous Catheter
- How many people
- 12,600 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2019to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients at the included hospitals who are receiving a central venous catheter insertions during the study period will be observed
Who may be able to join
- All patients receiving a central venous catheter will be observed
Who cannot join
- Patients that dies within 24 hours after insertion of a central venous catheter
Trial locations and contacts
1 site in 1 country.
About this study
Central venous catheters are common in modern health care and are being increasingly used in both intensive care units and general wards. The primary aim of this study is to determine the incidence of mechanical complications within 24 hours after central venous catheterisation. The secondary aim is to identify risk factors associated with mechanical complications within 24 hours after catheterisation.
Read the detailed description
Central venous catheters provide reliable access to the bloodstream, which allows delivery of medications and nutritional support that cannot be given safely through peripheral venous catheters.
Mechanical complications of central venous catheterisation include bleeding (such as hematoma and hemothorax), cardiac arrhythmia, arterial puncture, arterial catheterisation, nerve injury, pneumothorax, failed catheterisation and catheter tip malposition. The most common mechanical complications are arterial puncture, hematoma formation and pneumothorax. The number of mechanical complications related to central venous catheterisation varies widely in previous studies with incidences between 1.1 and 34 %. Ultrasound guidance reduces the incidence of mechanical complications, but despite evidence demonstrating improved safety, real-time ultrasound guidance is still not routinely used by all physicians when obtaining central venous access.
Four hospitals in Region Skåne, Sweden, will participate in this study: one university hospital with approximately 1300 beds and three county hospitals with about 200 beds each. All central venous catheter insertions at the participating hospitals during the study period will be included in the study.
The primary aim of this prospective, controlled, observational study is to determine the incidence of mechanical complications within 24 hours after central venous catheterisation. The secondary aim is to identify independent risk factors of mechanical complications within 24 hours after insertion of central venous catheters.
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) and grade 4 bleedings/hemothorax (life-threatening bleedings). Will be detected during the catheterisation or at the daily inspection by the patient responsible physician or nurse. Will be classified as major mechanical complications
Measured: Up to 24 hours after insertion of 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). 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 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 arterial puncture evident at the insertion procedure by the inserting physician
Mechanical complication after CVC-insertion. Will be detected by the inserting anesthesiologist and documented in the electronic chart. Will be considered a minor mechanical complication.
Measured: During the procedure of inserting the central venous catheter
Number of cases with arterially positioned catheter at post-procedural x-ray
Mechanical complication after CVC-insertion. Will be detected at a post-procedural x-ray of the thorax. Will be considered a major mechanical complication.
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 recognized by the responsible physician or nurse
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
Number of cases with transient nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function recognized by the responsible physician or nurse
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
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 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 failure to place the catheter
An attempt to insert a central venous catheter was performed but failed. Will be detected by the inserting anesthesiologist. Minor mechanical complications.
Measured: During the procedure of inserting the central venous catheter
Number of cases with catheter tip malposition at post-procedural x-ray, where correction is needed before use
Mechanical complication after CVC-insertion. Will be detected at a post-procedural x-ray of the thorax. Minor mechanical complications.
Measured: Up to 24 hours after insertion of 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 posted20 Dec 2018
- Study start1 Mar 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mechanical Complications of Central Venous CatheterStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 12,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Kander, Ass. Prof., Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782324
- Sponsor's protocol ID
- CVC-MECH
- Acronym
- CVC-MECH
- Status last verified
- Jan 2022
- First submitted
- 4 Dec 2018
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Naddi L, Hubinette J, Kander T, Borgquist O, Adrian M. Operator gender differences in major mechanical complications after central line insertions: a subgroup analysis of a prospective multicentre cohort study. BMC Anesthesiol. 2024 Feb 21;24(1):68. doi: 10.1186/s12871-024-02455-3.
PubMed 38383304Adrian M, Borgquist O, Kroger T, Linne E, Bentzer P, Spangfors M, Akeson J, Holmstrom A, Linner R, Kander T. Mechanical complications after central venous catheterisation in the ultrasound-guided era: a prospective multicentre cohort study. Br J Anaesth. 2022 Dec;129(6):843-850. doi: 10.1016/j.bja.2022.08.036. Epub 2022 Oct 22.
PubMed 36280461Adrian M, Borgquist O, Bentzer P, Akeson J, Spangfors M, Wrigstad J, Holmstrom A, Linner R, Kander T. Research protocol for mechanical complications after central venous catheterisation: a prospective controlled multicentre observational study to determine incidence and risk factors of mechanical complications within 24 hours after cannulation. BMJ Open. 2019 Oct 19;9(10):e029301. doi: 10.1136/bmjopen-2019-029301.
PubMed 31630102
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Complications After Central Venous Catheterisation
- ClinicalTrials.gov ID
- NCT03782324
- Acronym / sponsor ID
- CVC-MECH / CVC-MECH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,600 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Dec 2018 (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.
Central venous catheters are common in modern health care and are being increasingly used in both intensive care units and general wards. The primary aim of this study is to determine the incidence of mechanical complications within 24 hours after central venous catheterisation. The secondary aim is to identify risk factors associated with mechanical complications within 24 hours after catheterisation.
Detailed description
Central venous catheters provide reliable access to the bloodstream, which allows delivery of medications and nutritional support that cannot be given safely through peripheral venous catheters.
Mechanical complications of central venous catheterisation include bleeding (such as hematoma and hemothorax), cardiac arrhythmia, arterial puncture, arterial catheterisation, nerve injury, pneumothorax, failed catheterisation and catheter tip malposition. The most common mechanical complications are arterial puncture, hematoma formation and pneumothorax. The number of mechanical complications related to central venous catheterisation varies widely in previous studies with incidences between 1.1 and 34 %. Ultrasound guidance reduces the incidence of mechanical complications, but despite evidence demonstrating improved safety, real-time ultrasound guidance is still not routinely used by all physicians when obtaining central venous access.
Four hospitals in Region Skåne, Sweden, will participate in this study: one university hospital with approximately 1300 beds and three county hospitals with about 200 beds each. All central venous catheter insertions at the participating hospitals during the study period will be included in the study.
The primary aim of this prospective, controlled, observational study is to determine the incidence of mechanical complications within 24 hours after central venous catheterisation. The secondary aim is to identify independent risk factors of mechanical complications within 24 hours after insertion of central venous catheters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients at the included hospitals who are receiving a central venous catheter insertions during the study period will be observed
Key inclusion criteria (1 listed)
- All patients receiving a central venous catheter will be observed
Key exclusion criteria (1 listed)
- Patients that dies within 24 hours after insertion of a central venous catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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) and grade 4 bleedings/hemothorax (life-threatening bleedings). Will be detected during the catheterisation or at the daily inspection by the patient responsible physician or nurse. Will be classified as major mechanical complications
Number of cases with bleeding grad 2
Time frame: Up to 24 hours after insertion of the central venous catheter
Mechanical complication after CVC-insertion. Grade 2 bleedings/hematoma formation (bleedings requiring external compression). 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.
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 arterial puncture evident at the insertion procedure by the inserting physician
Time frame: During the procedure of inserting the central venous catheter
Mechanical complication after CVC-insertion. Will be detected by the inserting anesthesiologist and documented in the electronic chart. Will be considered a minor mechanical complication.
Number of cases with arterially positioned catheter at post-procedural x-ray
Time frame: Up to 24 hours after insertion of the central venous catheter
Mechanical complication after CVC-insertion. Will be detected at a post-procedural x-ray of the thorax. Will be considered a major mechanical complication.
Number of cases with persistent nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function recognized by the responsible physician or nurse
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.
Number of cases with transient nerve injury classified as sensory loss, paraesthesia or loss of motor neuron function recognized by the responsible physician or nurse
Time frame: Transient up to 72 hours after insertion of the central venous catheter
Mechanical complication after CVC-insertion. Will be detected and documented by the patient responsible nurse. Will be considered a minor mechanical complication.
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 arrhythmia grad 1-2 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 1 (asymptomatic arrhythmia not requiring intervention) and grade 2 (asymptomatic or symptomatic arrhythmia requiring non-urgent medical intervention) will be considered minor mechanical complications.
Number of cases with failure to place the catheter
Time frame: During the procedure of inserting the central venous catheter
An attempt to insert a central venous catheter was performed but failed. Will be detected by the inserting anesthesiologist. Minor mechanical complications.
Number of cases with catheter tip malposition at post-procedural x-ray, where correction is needed before use
Time frame: Up to 24 hours after insertion of central venous catheter
Mechanical complication after CVC-insertion. Will be detected at a post-procedural x-ray of the thorax. Minor mechanical complications.
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 12 Jan 2022.
- Derived from this study: PubMed 38383304Naddi L, Hubinette J, Kander T, Borgquist O, Adrian M. Operator gender differences in major mechanical complications after central line insertions: a subgroup analysis of a prospective multicentre cohort study. BMC Anesthesiol. 2024 Feb 21;24(1):68. doi: 10.1186/s12871-024-02455-3.
- Derived from this study: PubMed 36280461Adrian M, Borgquist O, Kroger T, Linne E, Bentzer P, Spangfors M, Akeson J, Holmstrom A, Linner R, Kander T. Mechanical complications after central venous catheterisation in the ultrasound-guided era: a prospective multicentre cohort study. Br J Anaesth. 2022 Dec;129(6):843-850. doi: 10.1016/j.bja.2022.08.036. Epub 2022 Oct 22.
- Derived from this study: PubMed 31630102Adrian M, Borgquist O, Bentzer P, Akeson J, Spangfors M, Wrigstad J, Holmstrom A, Linner R, Kander T. Research protocol for mechanical complications after central venous catheterisation: a prospective controlled multicentre observational study to determine incidence and risk factors of mechanical complications within 24 hours after cannulation. BMJ Open. 2019 Oct 19;9(10):e029301. doi: 10.1136/bmjopen-2019-029301.
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.
Thomas Kander, Ass. Prof. principal investigator
Skane University Hospital
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 Mechanical Complications of Central Venous Catheter, run by Region Skane 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 12 Jan 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 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 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03782324, which also lists 3 linked publications.
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 12 Jan 2022.