NCT03782324|Completed
Mechanical Complications After Central Venous Catheterisation
CVC-MECH
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CVC-MECH
Sponsor study identifier
observational
12,600
1 country
1
Study Start
March 1, 2019
Actual (reported)Primary Completion
December 31, 2020
Actual (reported)Study Completion
December 31, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 4, 2018
Actual (reported)December 20, 2018
Actual (reported)March 1, 2019
Actual (reported)December 31, 2020
Actual (reported)December 31, 2020
Actual (reported)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.
All patients at the included hospitals who are receiving a central venous catheter insertions during the study period will be observed
Region Skåne
Lund, Skåne County, Sweden
Naddi L, Hubinette J, Kander T, Borgquist O, Adrian M. Operator gender differences in major mechanical complications after central line insertions: a subgroup analysis of a prospective multicentre cohort study. BMC Anesthesiol. 2024 Feb 21;24(1):68. doi: 10.1186/s12871-024-02455-3.
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.
Thomas Kander, Ass. Prof.
Skane University Hospital
12,600 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2018
First Posted
December 20, 2018
Study Start
March 1, 2019
Actual (reported)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
Contact the study team to confirm eligibility.
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.
Primary Completion
December 31, 2020
Actual (reported)Study Completion
December 31, 2020
Actual (reported)Last Updated
January 12, 2022
Record last verified: 2022-01
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