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Trials / Completed

CompletedNCT03782324

Mechanical Complications After Central Venous Catheterisation

Status
Completed
Phase
Study type
Observational
Enrollment
12,600 (actual)
Sponsor
Region Skane · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Timeline

Start date
2019-03-01
Primary completion
2020-12-31
Completion
2020-12-31
First posted
2018-12-20
Last updated
2022-01-12

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT03782324. Inclusion in this directory is not an endorsement.