Immediate Mechanical Complications After Central Venous Catheterization

NCT07367620 | Completed

• 1 other identifier: CATH-RISK
• Study Type: observational
• Target: 29,114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Venous Access Complications

Keywords

central venous catheters; Catheterization, Central Venous; Vascular Access Devices

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  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.

  Persistent more than 72 hours after insertion of the central venous catheter

Secondary Outcomes (4)

• Number of cases with failure to place the catheter

  During the procedure of inserting the central venous catheter

• Number of cases with bleeding grad 2

  Up to 24 hours after insertion of the central venous catheter

• Number of cases with arrhythmia grad 1-2 during the inserting procedure

  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

  Transient up to 72 hours after insertion of the central venous catheter

Study Arms (1)

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.

Device: Central Venous Catheterization

Interventions

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.

Patients undergoing central venous catheterization

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Kander: lead
• Region Skane: collaborator
• Lund University: collaborator

Study Sites (1)

Region Skåne

Lund, Skåne County, Sweden

Location

MeSH Terms

Interventions

Catheterization, Central Venous

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 26, 2026
• Study Start: March 1, 2019
• Primary Completion: August 16, 2025
• Study Completion: April 17, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available beginning after publication of the primary study results, with no defined end date
• Access Criteria: De-identified individual participant data may be shared with qualified researchers upon reasonable request and approval by PI, in accordance with ethical and data protection regulations. Data will be shared via secure transfer after execution of a data use agreement

Locations

SE (1)