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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.

ABSTRACT: INTRODUCTION:Central venous catheterisation is a common procedure in intensive care therapy and the use of central venous catheters is essential for treatment of many medical disorders. Although rare, central venous catheterisation is associated with mechanical complications that can be life-threatening if untreated. Real-time ultrasound guidance reduces the incidence of mechanical complications when compared with the anatomic landmark method. The purpose of this study is to determine the incidence of and potential risk factors associated with early mechanical complications of central venous catheterisation in an era where real-time ultrasound guidance has become clinical practice. METHODS AND ANALYSIS:This is a prospective, controlled, multicentre, observational study. All participating hospitals follow the same clinical guidelines for central venous catheterisation. Each central venous catheter insertion will be recorded in the common electronic chart system according to a recently revised template. An automated script-based search will identify all recorded central venous catheter insertion templates during the study period and relevant variables will be extracted. Outcome measures and independent variables are pre-defined in this study protocol. Multivariable and univariable logistic regression analysis will be used to determine associations and risk factors of mechanical complications. ETHICS AND DISSEMINATION:The Regional Ethical Review Board in Lund, Sweden has approved this study. The results will be submitted for publication in peer-reviewed medical journals and presented at national and international scientific meetings. TRIAL REGISTRATION NUMBER:NCT03782324.

SUBMITTER: Adrian M

PROVIDER: S-EPMC6803156 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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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.

Adrian Maria M Borgquist Ola O Bentzer Peter P Åkeson Jonas J Spångfors Martin M Wrigstad Jonas J Holmström Anders A Linnér Rikard R Kander Thomas T

BMJ open 20191019 10

<h4>Introduction</h4>Central venous catheterisation is a common procedure in intensive care therapy and the use of central venous catheters is essential for treatment of many medical disorders. Although rare, central venous catheterisation is associated with mechanical complications that can be life-threatening if untreated. Real-time ultrasound guidance reduces the incidence of mechanical complications when compared with the anatomic landmark method. The purpose of this study is to determine th ...[more]

PMID: 31630102

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Project description:Background We retrospectively compared early- (<6 hours) versus late- (6-24 hours) presenting patients using perfusion-weighted imaging selection and evaluated clinical/radiographic outcomes. Methods and Results Large vessel occlusion patients treated with mechanical thrombectomy from August 2017 to July 2020 within 24 hours of onset were retrieved from a single-center database. Perfusion-weighted imaging was analyzed by automated software and final infarct volume was measured semi-automatically within 14 days. The primary end point was good outcome (modified Rankin Scale 0-2 at 90 days). Secondary end points were excellent outcome (modified Rankin Scale 0-1 at 90 days), symptomatic intracranial hemorrhage, and death. Clinical characteristics/radiological values including hypoperfusion volume and infarct growth velocity (baseline volume/onset-to-image time) were compared between the groups. Of 1294 patients, 118 patients were included. The median age was 74 years, baseline National Institutes of Health Stroke Scale score was 14, and core volume was 13 mL. The late-presenting group had more female patients (67% versus 31%, respectively; P=0.001). No statistically significant differences were seen in good outcome (42% versus 53%, respectively; P=0.30), excellent outcome (26% versus 32%, respectively; P=0.51), symptomatic intracranial hemorrhage (6.5% versus 4.6%, respectively; P=0.74), and death (3.2% versus 5.7%, respectively; P=0.58) between the groups. The late-presenting group had more atherothrombotic cerebral infarction (19% versus 6%, respectively; P=0.03), smaller hypoperfusion volume (median: 77 versus 133 mL, respectively; P=0.04), and slower infarct growth velocity (median: 0.6 versus 5.1 mL/h, respectively; P=0.03). Conclusions Patients with early- and late-time windows treated with mechanical thrombectomy by automated perfusion-weighted imaging selection have similar outcomes, comparable with those in randomized trials, but different in infarct growth velocities. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02251665.

Project description:OBJECTIVES:To assess the evidence for the clinical effectiveness of ultrasound guided central venous cannulation. DATA SOURCES:15 electronic bibliographic databases, covering biomedical, science, social science, health economics, and grey literature. DESIGN:Systematic review and meta-analysis of randomised controlled trials. Populations Patients scheduled for central venous access. INTERVENTION REVIEWED: Guidance using real time two dimensional ultrasonography or Doppler needles and probes compared with the anatomical landmark method of cannulation. DATA EXTRACTION:Risk of failed catheter placement (primary outcome), risk of complications from placement, risk of failure on first attempt at placement, number of attempts to successful catheterisation, and time (seconds) to successful catheterisation. DATA SYNTHESIS:18 trials (1646 participants) were identified. Compared with the landmark method, real time two dimensional ultrasound guidance for cannulating the internal jugular vein in adults was associated with a significantly lower failure rate both overall (relative risk 0.14, 95% confidence interval 0.06 to 0.33) and on the first attempt (0.59, 0.39 to 0.88). Limited evidence favoured two dimensional ultrasound guidance for subclavian vein and femoral vein procedures in adults (0.14, 0.04 to 0.57 and 0.29, 0.07 to 1.21, respectively). Three studies in infants confirmed a higher success rate with two dimensional ultrasonography for internal jugular procedures (0.15, 0.03 to 0.64). Doppler guided cannulation of the internal jugular vein in adults was more successful than the landmark method (0.39, 0.17 to 0.92), but the landmark method was more successful for subclavian vein procedures (1.48, 1.03 to 2.14). No significant difference was found between these techniques for cannulation of the internal jugular vein in infants. An indirect comparison of relative risks suggested that two dimensional ultrasonography would be more successful than Doppler guidance for subclavian vein procedures in adults (0.09, 0.02 to 0.38). CONCLUSIONS:Evidence supports the use of two dimensional ultrasonography for central venous cannulation.

Dataset Information

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.

Publications

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.

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