Mechanical Complications After Central Venous Catheterisation (CVC-MECH)

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.

Study Overview

• Status: Completed
• Conditions: Mechanical Complications of Central Venous Catheter

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 Type: Observational
• Enrollment (Actual): 12600

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden
      • Region Skane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients at the included hospitals who are receiving a central venous catheter insertions during the study period will be observed

Description

Inclusion Criteria:

• All patients receiving a central venous catheter will be observed

Exclusion Criteria:

• Patients that dies within 24 hours after insertion of a central venous catheter

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	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.	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.	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.	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.	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.	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.	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.	Up to 24 hours after insertion of central venous catheter

Collaborators and Investigators

• Sponsor: Region Skane

Publications and helpful links

General Publications

• Adrian 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.
• Adrian 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. Erratum In: BMJ Open. 2019 Dec 17;9(12):e029301corr1.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 18, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CVC-MECH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No