Clinical trial NCT03782324: Mechanical Complications After Central Venous Catheterisation
Official title: Mechanical Complications After Central Venous Catheterisation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Complications of Central Venous Catheter
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 12600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of cases with bleeding grade 3-4
timeFrame: Up to 24 hours after insertion of the central venous catheter
measure: Number of cases with bleeding grad 2
timeFrame: Up to 24 hours after insertion of the central venous catheter
measure: Number of cases with pneumothorax at post-procedural x-ray of the thorax
timeFrame: Up to 24 hours after insertion of the central venous catheter
measure: Number of cases with arterial puncture evident at the insertion procedure by the inserting physician
timeFrame: During the procedure of inserting the central venous catheter
measure: Number of cases with arterially positioned catheter at post-procedural x-ray
timeFrame: Up to 24 hours after insertion of the central venous catheter
measure: 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
timeFrame: Persistent more than 72 hours after insertion of the central venous catheter
measure: 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
timeFrame: Transient up to 72 hours after insertion of the central venous catheter
measure: Number of cases with arrhythmia grad 3-4 during the inserting procedure
timeFrame: During the procedure of inserting the central venous catheter
measure: Number of cases with arrhythmia grad 1-2 during the inserting procedure
timeFrame: During the procedure of inserting the central venous catheter
measure: Number of cases with failure to place the catheter
timeFrame: During the procedure of inserting the central venous catheter
measure: Number of cases with catheter tip malposition at post-procedural x-ray, where correction is needed before use
timeFrame: Up to 24 hours after insertion of central venous catheter
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Region Skåne
state: Skåne
Study officials:
affiliation: Skane University Hospital
name: Thomas Kander, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.