Mechanical Complications After Central Venous Catheterisation

NCT ID: NCT03782324

Last Updated: 2022-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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

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Mechanical Complications of Central Venous Catheter

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Kander, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Skane University Hospital

Locations

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Region Skåne

Lund, Skåne County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 38383304 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36280461 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31630102 (View on PubMed)

Other Identifiers

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CVC-MECH

Identifier Type: -

Identifier Source: org_study_id

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