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Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial.

ABSTRACT: Central venous catheters play an important role in patient care. Real-time ultrasound-guided subclavian central venous (SCV) cannulation may reduce the incidence of complications and the time between skin penetration and the aspiration of venous blood into the syringe. Ultrasonic diagnosis of catheter misplacement and pneumothorax related to central venous catheterization is rapid and accurate. It is unclear, however, whether ultrasound real-time guidance and examination can reduce procedure times and complication rates when compared with landmark guidance and radiographic examination for SCV catheterization.The Subclavian Central Venous Catheters Guidance and Examination by UltraSound (SUBGEUS) study is an investigator-initiated single center, randomized, controlled two-arm trial. Three hundred patients undergoing SCV catheter placement will be randomized to ultrasound real-time guidance and examination or landmark guidance and radiographic examination. The primary outcome is the time between the beginning of the procedure and control of the catheter. Secondary outcomes include the times required for the six components of the total procedure, the occurrence of complications (pneumothorax, hemothorax, or misplacement), failure of the technique and occurrence of central venous catheter infections.The SUBGEUS trial is the first randomized controlled study to investigate whether ultrasound real-time guidance and examination for SCV catheter placement reduces all procedure times and the rate of complications.ClinicalTrials.gov Identifier: NCT01888094.

SUBMITTER: Perbet S

PROVIDER: S-EPMC4031378 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial.

Perbet Sébastien S Pereira Bruno B Grimaldi Florian F Dualé Christian C Bazin Jean-Etienne JE Constantin Jean-Michel JM

Trials 20140520

<h4>Background</h4>Central venous catheters play an important role in patient care. Real-time ultrasound-guided subclavian central venous (SCV) cannulation may reduce the incidence of complications and the time between skin penetration and the aspiration of venous blood into the syringe. Ultrasonic diagnosis of catheter misplacement and pneumothorax related to central venous catheterization is rapid and accurate. It is unclear, however, whether ultrasound real-time guidance and examination can r ...[more]

PMID: 24885789

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Project description:BACKGROUND:Ultrasound guidance for central venous catheterization is a commonly used alternative to the conventional landmark method. Because from the German perspective, the cost-effectiveness of ultrasound guidance is unclear, this study examined the cost-effectiveness of ultrasound guidance versus the landmark method for adults undergoing a central venous catheterization. METHODS:A decision-tree based model was built to estimate the costs of averted catheter-related complications. Clinical data (e.g. arterial puncture, failed attempts) were obtained from a Cochrane review and a randomized controlled trial, whilst information about cost parameters were taken from a German hospital of maximum care. The analysis was conducted from the perspective of the German Statutory Health Insurance. Results were presented as incremental cost-effectiveness ratios. To assess the parameter uncertainty, several sensitivity analyses were performed (deterministic, probabilistic and with regard to the model structure). RESULTS:Our analysis revealed that ultrasound guidance resulted in fewer complications per person (0.04 versus 0.17 for the landmark method) and was less expensive (€51 versus €230 for the landmark method). Results were robust to changes in the model parameters and in the model structure. Whilst our model population reflected approximately 49% of adults undergoing a central venous catheterization cannulation per year, structural sensitivity analyses (e.g. extending the study cohort to patients at higher baseline risk of complications, pediatric patients, or using real-time/indirect catheterization) indicated the cost-effectiveness of ultrasound guidance for a broader spectrum of patients. The results should be interpreted by considering the assumptions (e.g. target population) and approximations (e.g. cost parameters) underpinning the model. CONCLUSIONS:Ultrasound guidance for central venous catheterization averts more catheter-related complications and may save the resources of the German Statutory Health Insurance compared with landmark method.

Project description:BackgroundNeonates and small infants with congenital cardiac disease undergoing cardiac surgery represent major challenges facing paediatric anaesthesia and perioperative medicine.AimsWe here aimed to investigate the success rates in performing ultrasound (US) guided central venous catheter insertion (CVC) in neonates and small infants undergoing cardiac surgery, and to evaluate the practicability and feasibility of thereby using a novel wireless US transducer (WUST).MethodsThirty neonates and small infants with a maximum body weight of 10 kg and need for CVC before cardiac surgery were included in this observational trial and were subdivided into two groups according to their weight: < 5 kg and ≥ 5 kg. Cannulation success, failure rate, essential procedure related time periods, and complications were recorded and the clinical utility of the WUST was assessed by a 5-point Likert scale.ResultsIn total, CVC-insertion was successful in 27 (90%) of the patients and the first attempt was successful in 24 (78%) of patients. Success rates of CVC were 80% < 5 kg and 100% ≥5 kg. Comparing the two groups we found a clear trend towards longer needle insertion time in patients weighing < 5 kg (33 [28-69] vs. 24 [15-37]s, P = .07), whereas, the total time for catheter insertion and the duration of the whole procedure were similar in both groups (199 [167-228] vs. 178 [138-234] and 720[538-818] vs. 660 [562-833]s. In total, we report 3 (10%) cases of local hematoma as procedure-related complications. Assessments of the WUST revealed very good survey results for all parameters of practicability and handling (all ratings between 4.5 and 5.0).ConclusionAlthough difficulties in CVC-placement seem to relate to vessel size and patient's weight, US guided CVC-insertion represents a valuable, fast, and safe intervention in neonates and small children undergoing cardiac surgery. Using the WUST is feasible for this clinical application and may aid in efforts aiming to optimize perioperative care.Trial registrationWireless US-guided CVC placement in infants; Clinicaltrials.gov: NCT04597021 ; Date of Registration: 21October, 2020; retrospectively registered.

Project description:Accumulating evidence shows that ultrasound (US) guidance improves effectiveness and safety of central venous catheter (CVC) placement. Several international guidelines therefore recommend the use of US for placement of CVCs. However, surveys show that the landmark-based technique is still widely used, while the percentage of physicians using US is increasing less than expected. The goal of this study was to investigate current practice for central venous catheterization in anaesthesiology and intensive care in the Netherlands, identify barriers for further implementation of US guidance and to evaluate whether personality traits are associated with the choice of technique. We conducted a web-based national survey, distributed among members of the Dutch societies of anaesthesiology (NVA) and intensive care (NVIC). The survey contained questions regarding physician and hospital characteristics, frequency of US use and reasons for use or non-use, as well as the NEO-FFI-3, a validated, translated questionnaire to characterize personality traits according to the 'Big Five' concept. Response rate was 22% (506/2291), of which 400 had also the personality questionnaire complete. Ultrasound guidance was used always or almost always in 68%; barriers for US use were working in a non-academic non-teaching hospital, providing cardiac anaesthesia and more years of physician experience. Reasons for not using US were perceived lack of benefit, increased procedure time, lack of US equipment and fear of loss of landmark technique skills. 13% of respondents had never experienced a complication during CVC placement, and 67% knew of a complication occurring the past year at their department. Ultrasound was thought not to be able to prevent the complication in half of these cases. Of the personality traits, only neuroticism and extraversion showed a minor positive association with US guidance. A majority of anaesthesiologists and intensivists uses US guidance for CVC placement, but a significant proportion of physicians still prefers the landmark technique. Most arguments from respondents against US guidance can be challenged. Personality traits most likely do not play a major role in the acceptance of US guidance for central venous catheterization. A potential intervention to increase US use could be formalizing local hospital policies mandating compliance with US guidance. Future research can perhaps focus on cognitive biases that currently limit more widespread use of US guidance.

Dataset Information

Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial.

Publications

Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial.

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