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Completed

NCT Number: NCT07367620

Immediate Mechanical Complications After Central Venous Catheterization

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Region Skåne

Lund, Skåne County, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients receiving a central venous catheter within the study period will be observed

Exclusion criteria

  • 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

Treatment and study plan

Central Venous Catheterization

Device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Secondary outcomes

  1. 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. Will be classified as minor mechanical complications.

  2. 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) 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.

  3. 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.

  4. 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

    Mechanical complication after CVC-insertion. Will be detected and documented by the patient responsible nurse. Will be considered a minor mechanical complication.

Sponsors and collaborators

Lead sponsor

Thomas Kander

Other

Collaborators

  • Lund University
  • Region Skane

Registry information

Official study title

Immediate Mechanical Complications After Central Venous Catheterization; a Multicentre Cohort Study

Acronym: CATH-RISK

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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