Immediate Mechanical Complications After Central Venous Catheterization; a Multicentre Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29,114
- 试验地点
- 1
- 主要终点
- Number of cases with bleeding grade 3-4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients receiving a central venous catheter within the study period will be observed
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Central Venous Catheterization (Device)
结局指标
主要结局
Number of cases with bleeding grade 3-4
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Thomas Kander
Professor
Region Skane