Use of a hydrophilic coating wire reduces significantly the rate of central vein punctures and the incidence of pneumothorax in totally implantable access port (TIAP) surgery

Background: Insertion of a Totally Implantable Access Port (TIAP) can be performed either via Central Vein Puncture (CVP) or Brachiocephalic Vein Cut-down (venous section-VS). The primary success rate of TIAP implantation using VS rarely ever achieves 100%. The objective of this study was to describe a modified VS approach using a hydrophilic coated wire (TVS). Methods: From 01.01.2015 to 31.12.2015, all patients receiving TIAP implantations were screened. During this time, all patients in whom the primary VS procedure was found to be unsuccessful were analysed. Results: In 2015, 1152 patients had TIAP implantations performed by 24 different surgeons. Of these, 277 patients needed a second line rescue strategy either by CVP (n= 69) or TVS (n= 208). There were no statistically significant differences regarding demographics or indication for TIAP implantation between CVP and TVS. The operation time and the qualification of the operating surgeon between CVP and TVS did not differ significantly. After the introduction of the guidewire with a hydrophilic coated wire, the need for CVP decreased significantly from 12.7% to 8.8% (p< 0.0001). In patients receiving CVP as a second line rescue strategy, the incidence of pneumothorax (n= 3 patients (4.3%)) was significantly higher compared to patients with TVS as a second line rescue strategy (n= 1 patient (0.48%),p=0.02). Conclusion: The use of a hydrophilic coated wire significantly decreased the number of CVP and the incidence of pneumothorax. TVS is a safe and successful second-line rescue strategy

Frequency of pneumothorax and haemothorax after primary open versus closed implantation strategies for insertion of a totally implantable venous access port in oncological patients: study protocol for a randomised controlled trial

Background: The insertion of central venous access devices, such as totally implantable venous access ports (TIVAPs), is routine in patients who need a safe and permanent venous access. The number of port implantations is increasing due to the development of innovative adjuvant and neo-adjuvant therapies. Currently, two different strategies are being routinely used: surgical cut-down of the cephalic vein (vena section) and direct puncture of the subclavian vein. The aim of this trial is to identify the strategy for the implantation of TIVAPs with the lowest risk of pneumothorax and haemothorax. Methods/Design: The PORTAS-3 trial is designed as a multicentre, randomised controlled trial to compare two implantation strategies. A total of 1,154 patients will be randomised after giving written informed consent. Patients must be over 18 years of age and scheduled for primary implantation of a TIVAP on the designated side. The primary endpoint will be the frequency of pneumothorax and haemothorax after insertion of a TIVAP by one of two different strategies. The experimental intervention is as follows: open strategy, defined as surgical cut-down of the cephalic vein, supported by a rescue technique if necessary, and in the case of failure, direct puncture of the subclavian vein. The control intervention is as follows: direct puncture of the subclavian vein using the Seldinger technique guided by sonography, fluoroscopy or landmark technique. The trial duration is approximately 36 months, with a recruitment period of 18 months and a follow-up period of 30 days. Discussion: The PORTAS-3 trial will compare two different TIVAP implantation strategies with regard to their individual risk of postoperative pneumothorax and haemothorax. Since TIVAP implantation is one of the most common procedures in general surgery, the results will be of interest for a large community of surgeons as well as oncologists and general practitioners. The pragmatic trial design ensures that the results will be generalizable to a wide range of patients. Trial registration: The trial protocol was registered on 28 August 2014 with the German Clinical Trials Register (DRKS00004900). The World Health Organization’s Universal Trial Number is U1111-1142-4420

Insertion of totally implantable venous access devices: an expertise-based, randomized, controlled trial (NCT00600444)

Comparison of two different insertion techniques for implantation of totally implantable access ports (TIAP)

Guidance on classification for reproductive toxicity under the globally harmonized system of classification and labelling of chemicals (GHS)

With a wider remit, the United Nations formulated a classification and labelling system for universal application, the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The GHS was first published in 2003 (UN, 2003) and subsequently updated on a biannual basis, with the most recent revision published in 2009 (UN, 2009a). It was enacted into the European legislative framework as Regulation 1272/2008 (EC, 2008). The supplementary guidance text of the GHS explains the application of the classification criteria (Box 1). It uses more advisory, less obligatory, language than the equivalent EU text (e.g. “should” vs. “shall”), but overall the differences between the two are minor and are noted in the footnotes to Box 1. This review offers guidance for the classification of substances for toxicity to reproduction according to the GHS; as a whole it applies equally to both regulatory frameworksJRC.I.5-Systems Toxicolog

Preferred learning modalities and practice for critical skills: A global survey of paediatric emergency medicine clinicians

© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ. Objective To describe senior paediatric emergency clinician perspectives on the optimal frequency of and preferred modalities for practising critical paediatric procedures. Methods Multicentre multicountry cross-sectional survey of senior paediatric emergency clinicians working in 96 EDs affiliated with the Pediatric Emergency Research Network. Results 1332/2446 (54%) clinicians provided information on suggested frequency of practice and preferred learning modalities for 18 critical procedures. Yearly practice was recommended for six procedures (bag valve mask ventilation, cardiopulmonary resuscitation (CPR), endotracheal intubation, laryngeal mask airway insertion, defibrillation/direct current (DC) cardioversion and intraosseous needle insertion) by at least 80% of respondents. 16 procedures were recommended for yearly practice by at least 50% of respondents. Two procedures (venous cutdown and ED thoracotomy) had yearly practice recommended b

Preferred learning modalities and practice for critical skills: a global survey of paediatric emergency medicine clinicians

Objective To describe senior paediatric emergency clinician perspectives on the optimal frequency of and preferred modalities for practising critical paediatric procedures. Methods Multicentre multicountry cross-sectional survey of senior paediatric emergency clinicians working in 96 EDs affiliated with the Pediatric Emergency Research Network. Results 1332/2446 (54%) clinicians provided information on suggested frequency of practice and preferred learning modalities for 18 critical procedures. Yearly practice was recommended for six procedures (bag valve mask ventilation, cardiopulmonary resuscitation (CPR), endotracheal intubation, laryngeal mask airway insertion, defibrillation/direct current (DC) cardioversion and intraosseous needle insertion) by at least 80% of respondents. 16 procedures were recommended for yearly practice by at least 50% of respondents. Two procedures (venous cutdown and ED thoracotomy) had yearly practice recommended by <40% of respondents. Simulation was the preferred learning modality for CPR, bag valve mask ventilation, DC cardioversion and transcutaneous pacing. Practice in alternative clinical settings (eg, the operating room) was the preferred learning modality for endotracheal intubation and laryngeal mask insertion. Use of models/mannequins for isolated procedural training was the preferred learning modality for all other invasive procedures. Free-text responses suggested the utility of cadaver labs and animal labs for more invasive procedures (thoracotomy, intercostal catheter insertion, open surgical airways, venous cutdown and pericardiocentesis). Conclusions Paediatric ED clinicians suggest that most paediatric critical procedures should be practised at least annually. The preferred learning modality depends on the skill practised; alternative clinical settings are thought to be most useful for standard airway manoeuvres, while simulation-based experiential learning is applicable for most other procedures