Ultrasound-guided Placement of Single-lumen Peripheral Intravenous Catheters in the Internal Jugular Vein.

INTRODUCTION: The peripheral internal jugular (IJ), also called the "easy IJ," is an alternative to peripheral venous access reserved for patients with difficult intravenous (IV) access. The procedure involves placing a single-lumen catheter in the IJ vein under ultrasound (US) guidance. As this technique is relatively new, the details regarding the ease of the procedure, how exactly it should be performed, and the safety of the procedure are uncertain. Our primary objective was to determine the success rate for peripheral IJ placement. Secondarily, we evaluated the time needed to complete the procedure and assessed for complications. METHODS: This was a prospective, single-center study of US-guided peripheral IJ placement using a 2.5-inch, 18-gauge catheter on a convenience sample of patients with at least two unsuccessful attempts at peripheral IV placement by nursing staff. Peripheral IJ lines were placed by emergency medicine (EM) attending physicians and EM residents who had completed at least five IJ central lines. All physicians who placed lines for the study watched a 15-minute lecture about peripheral IJ technique. A research assistant monitored each line to assess for complications until the patient was discharged. RESULTS: We successfully placed a peripheral IJ in 34 of 35 enrolled patients (97.1%). The median number of attempts required for successful cannulation was one (interquartile range (IQR): 1 to 2). The median time to successful line placement was 3 minutes and 6 seconds (IQR: 59 seconds to 4 minutes and 14 seconds). Two lines failed after placement, and one of the 34 successfully placed peripheral IJ lines (2.9%) had a complication - a local hematoma. There were, however, no arterial punctures or pneumothoraces. Although only eight of 34 lines were placed using sterile attire, there were no line infections. CONCLUSION: Our research adds to the growing body of evidence supporting US-guided peripheral internal jugular access as a safe and convenient procedure alternative for patients who have difficult IV access.

The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP).

BACKGROUND: Cellulitis is a painful, potentially serious, infectious process of the dermal and subdermal tissues and represents a significant disease burden. The statistical analysis plan (SAP) for the Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial is described here. The PEDOCELL trial is a multicentre, randomised, parallel-arm, double-blinded, non-inferiority clinical trial comparing the efficacy of flucloxacillin (monotherapy) with combination flucloxacillin/phenoxymethylpenicillin (dual therapy) for the outpatient treatment of cellulitis in the emergency department (ED) setting. To prevent outcome reporting bias, selective reporting and data-driven results, the a priori-defined, detailed SAP is presented here. METHODS/DESIGN: Patients will be randomised to either orally administered flucloxacillin 500 mg four times daily and placebo or orally administered 500 mg of flucloxacillin four times daily and phenoxymethylpenicillin 500 mg four times daily. The trial consists of a 7-day intervention period and a 2-week follow-up period. Study measurements will be taken at four specific time points: at patient enrolment, day 2-3 after enrolment and commencing treatment (early clinical response (ECR) visit), day 8-10 after enrolment (end-of-treatment (EOT) visit) and day 14-21 after enrolment (test-of-cure (TOC) visit). The primary outcome measure is investigator-determined clinical response measured at the TOC visit. The secondary outcomes are as follows: lesion size at ECR, clinical treatment failure at each follow-up visit, adherence and persistence of trial patients with orally administered antibiotic therapy at EOT, health-related quality of life (HRQoL) and pharmacoeconomic assessments. The plan for the presentation and comparison of baseline characteristics and outcomes is described in this paper. DISCUSSION: This trial aims to establish the non-inferiority of orally administered flucloxacillin monotherapy with orally administered flucloxacillin/phenoxymethylpenicillin dual therapy for the ED-directed outpatient treatment of cellulitis. In doing so, this trial will bridge a knowledge gap in this understudied and common condition and will be relevant to clinicians across several different disciplines. The SAP for the PEDOCELL trial was developed a priori in order to minimise analysis bias. TRIAL REGISTRATION: EU Clinical Trials Register (EudraCT number: 2016-001528-69). Registered on 5 April 2016. ClinicalTrials.gov, ID: NCT02922686 . Registered on 9 August 2016.

A method to assess adherence in inhaler use through analysis of acoustic recordings of inhaler events.

RATIONALE: Poor adherence to inhaler use can be due to poor temporal and/or technique adherence. Up until now there has been no way of reliably tracking both these factors in everyday inhaler use. OBJECTIVES: This paper introduces a device developed to create time stamped acoustic recordings of an individual's inhaler use, in which empirical evidence of temporal and technique adherence in inhaler use can be monitored over time. The correlation between clinical outcomes and adherence, as determined by this device, was compared for temporal adherence alone and combined temporal and technique adherence. FINDINGS: The technology was validated by showing that the doses taken matched the number of audio recordings (r2 = 0.94, p<0.01). To demonstrate that audio analysis of inhaler use gives objective information, in vitro studies were performed. These showed that acoustic profiles of inhalations correlated with the peak inspiratory flow rate (r2 = 0.97, p<0.01), and that the acoustic energy of exhalations into the inhaler was related to the amount of drug removed. Despite training, 16% of participants exhaled into the mouthpiece after priming, in >20% of their inhaler events. Repeated training reduced this to 7% of participants (p = 0.03). When time of use was considered, there was no evidence of a relationship between adherence and changes in AQLQ (r2 = 0.2) or PEFR (r2 = 0.2). Combining time and technique the rate of adherence was related to changes in AQLQ (r2 = 0.53, p = 0.01) and PEFR (r2 = 0.29, p = 0.01). CONCLUSIONS: This study presents a novel method to objectively assess how errors in both time and technique of inhaler use impact on clinical outcomes. TRIAL REGISTRATION: EudraCT 2011-004149-42.

Standard requirements for GCP-compliant data management in multinational clinical trials.

BACKGROUND: A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. METHODS: International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. RESULTS: The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit. Section IN01 is dedicated to international aspects and ST01 to the competence of a trials unit's staff. CONCLUSIONS: The standard is intended to provide an open and widely used set of requirements for GCP-compliant data management, particularly in academic trial units. It is the intention that ECRIN will use these requirements as the basis for the certification of ECRIN data centres.

Emergency physician practices and requirements regarding the medical screening examination of psychiatric patients.

OBJECTIVE: To describe the testing requirements and practices of emergency physicians (EPs) when conducting a medical screening examination of psychiatric patients. METHODS: An anonymous survey was developed and mailed to 500 EPs randomly selected through American College of Emergency Physicians membership rolls. RESULTS: Two hundred ninety surveys were returned (58%). Eighty-five percent of the respondents were male, 70% practiced in a community setting and 28% in an academic setting, 58% were emergency medicine (EM) residency-trained, and 88% were EM board-certified or board-eligible. Ninety-eight percent stated they were actively involved with the psychiatric medical screening exam (PMSE). Routine testing was required by 35% of the respondents, with 16% being required by ED protocol, and 84% by the psychiatrist/psychiatric institute. Of those with required testing, tests required were: complete blood cell count (56%), electrolytes (56%), serum alcohol (85%), serum toxicology screen (31%), urine toxicology screen (86%), electrocardiogram (18%), liver function test (16%), blood urea nitrogen (45%), and creatinine (40%). Many clinicians believed that certain tests were unnecessary as part of a PMSE. There was no statistical difference between the opinions of the physicians required to test and those not required to test in terms of which tests they thought were a necessary part of a PMSE regardless of the patient's clinical presentation. The EM-trained physicians were also found to be significantly less likely to think certain tests were necessary for the PMSE when compared with the non-EM-trained physicians. CONCLUSIONS: Routine testing was required as part of the medical screening examination of psychiatric patients for only one-third of the respondents. Few respondents believed that any of these tests were necessary. Emergency medicine-trained physicians were less likely to feel that routine testing was necessary.