NCT07367620

Immediate Mechanical Complications After Central Venous Catheterization

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 29,500 (estimated)
• Sponsor: Thomas Kander · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Central Venous Access Complications

Interventions

Type	Name	Description
DEVICE	Central Venous Catheterization	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.

Timeline

• Start date: 2019-03-01
• Primary completion: 2025-08-16
• Completion: 2026-02-06
• First posted: 2026-01-26
• Last updated: 2026-02-06

Locations

1 site across 1 country: Sweden