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Mechanical Complications After Central Venous Catheterisation (CVC-MECH)

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ClinicalTrials.gov Identifier: NCT03782324
Recruitment Status : Not yet recruiting
First Posted : December 20, 2018
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Region Skane

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.

Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mechanical Complications After Central Venous Catheterisation
Estimated Study Start Date : January 31, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021



Primary Outcome Measures :
  1. Number of cases with bleeding grade 3-4 [ Time Frame: 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) 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

  2. Number of cases with bleeding grad 2 [ Time Frame: Up to 24 hours after insertion of the central venous catheter ]
    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.

  3. Number of cases with pneumothorax at post-procedural x-ray of the thorax [ Time Frame: 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

  4. Number of cases with arterial puncture evident at the insertion procedure by the inserting physician [ Time Frame: During the procedure of inserting the central venous catheter ]
    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.

  5. Number of cases with arterially positioned catheter at post-procedural x-ray [ Time Frame: Up to 24 hours after insertion of the central venous catheter ]
    Mechanical complication after CVC-insertion. Will be detected at a post-procedural x-ray of the thorax. Will be considered a major mechanical complication.

  6. 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 [ Time Frame: 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.

  7. 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 [ Time Frame: Transient up to 72 hours after insertion of the central venous catheter ]
    Mechanical complication after CVC-insertion. Will be detected and documented by the patient responsible nurse. Will be considered a minor mechanical complication.

  8. Number of cases with arrhythmia grad 3-4 during the inserting procedure [ Time Frame: 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.

  9. Number of cases with arrhythmia grad 1-2 during the inserting procedure [ Time Frame: 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 1 (asymptomatic arrhythmia not requiring intervention) and grade 2 (asymptomatic or symptomatic arrhythmia requiring non-urgent medical intervention) will be considered minor mechanical complications.

  10. Number of cases with failure to place the catheter [ Time Frame: During the procedure of inserting the central venous catheter ]
    An attempt to insert a central venous catheter was performed but failed. Will be detected by the inserting anesthesiologist. Minor mechanical complications.

  11. Number of cases with catheter tip malposition at post-procedural x-ray, where correction is needed before use [ Time Frame: Up to 24 hours after insertion of central venous catheter ]
    Mechanical complication after CVC-insertion. Will be detected at a post-procedural x-ray of the thorax. Minor mechanical complications.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782324


Contacts
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Contact: Thomas Kander, Ass. Prof. +4646171156 thomas.kander@med.lu.se
Contact: Maria Adrian, M.D. +4646171156 maria.adrian@med.lu.se

Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Thomas Kander, Ass. Prof. Skane University Hospital

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT03782324     History of Changes
Other Study ID Numbers: CVC-MECH
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No