ABSTRACT
INTRODUCTION: First-insertion success rates for peripheral vascular access devices (PVADs) in patients with difficult venous access (DIVA) are low, which negatively affects staff workload, patient experience, and organizational cost. There is mixed evidence regarding the impact of a peripheral vascular access device with retractable coiled tip guidewire (GW; AccuCath™, BD) on the first-insertion success rate. The aim of this study is to investigate whether the use of long GW-PVADs, compared with standard PVADs, reduces the risk of first-time insertion failure, in patients admitted to emergency departments (EDs). METHODS AND ANALYSIS: A parallel-group, two-arm, randomized controlled trial will be carried out in two Australian EDs to compare long GW-PVADs (5.8 cm length) against standard care PVADs (short or long). Patients ≥18 years of age meeting DIVA criteria will be eligible for the trial. The sample size is 203 participants for each arm. Web-based central randomization will be used to ensure allocation concealment. Neither clinicians nor patients can be blinded to treatment allocation. Primary outcome is the first-insertion success rate. Secondary outcomes include the number of insertion attempts, time to insert PVAD, all-cause failure, dwell-time, patient-reported pain, serious adverse events, complications, subsequent vascular access devices required, patient satisfaction, staff satisfaction, and healthcare costs. Differences between the two groups will be analyzed using Cox proportional hazards regression. Cost-effectiveness analysis will also be conducted. Intention-to-treat analysis will be used. ETHICS AND DISSEMINATION: The study is approved by Metro South Ethics Committee (HREC/2022/QMS/82264) and Griffith University (2022/077). The findings will be published in a peer-reviewed journal. TRIAL REGISTRATION: ACTRN12622000299707.
Subject(s)
Catheterization, Peripheral , Hospitalization , Humans , Administration, Intravenous , Australia , Catheterization, Peripheral/adverse effects , Catheters , Emergency Service, Hospital , Randomized Controlled Trials as Topic , Adolescent , Young Adult , Adult , Middle Aged , Aged , Aged, 80 and overABSTRACT
BACKGROUND: Determination of fluid responsiveness (FR) associated with intravascular fluid resuscitation in hypotensive patients poses a challenge, with current best evidence methods fraught with poor retest reliability and difficulty in image acquisition (Osman, Crit Care Med 2007; 35: 64; Marik, Crit Care Med 2009; 37: 2642). Doppler carotid blood flow with passive leg raise (PLR) is a recent modality for determining FR (Marik, Chest 2013; 143: 364). PURPOSE: This study aimed to determine whether emergency physicians with limited ultrasound experience can reliably acquire this skill. METHOD: This prospective study recruited 60 emergency physicians with varying experience, who underwent a 3-step learning programme. Participants performed carotid velocity time integral (VTi) Doppler on healthy subjects, followed by repeat measurements in the PLR position. A 16-point checklist and time recorded were assessed for each sonographer, with each participant completing a post-study questionnaire to evaluate perceived competence and ease of skill acquisition. RESULTS: Of the 60 emergency physicians recruited, 37 (61.6%) were inexperienced and 23 (38.4%) were experienced. Against the 16-point assessment, 61% completed assessment without any errors. Fifty-six out of 60 (94.3%) completed the assessment to acceptable standard with errors recognised and corrected, and four participants (6.7%) made critical errors without correction (Figure 1). Average (±SEM) total scan time was 4:52 ± 0:19, with no significant difference found between inexperienced and experienced groups. CONCLUSIONS: This study demonstrated feasibility to train emergency physicians, demonstrating that average FR assessment was obtained within 5 min, with no difference between prior experience in scan quality/time taken. 94% completed the scan to acceptable standards, demonstrating ease of carotid Doppler flow with PLR to provide critical information in management of the hypotensive patient.
ABSTRACT
Este estudo foi conduzido para avaliar a biodisponibilidade de uma nova formulação de isotretinoína sistêmica e de seu principal metabólico, a 4-oxo-ísotretinoína, relativo a um produto referência. Os dados das concentrações plasmáticas foram coletadas em 36 indivíduos sadios, em um delineamento cruzado de 2 vias, por um período de tempo de 144 horas. O plasma das amostras sanguíneas foram analisadas por um ensaio cromatográfico validado. Medidas farmacocinéticas indicadoras das taxas de absorção e eliminação dos fármacos, como concentração máxima (Cmax), área sob a curva de concentração até o tempo final de coleta t (Auc) e a área estimada até o infinito (Auc) foram analisadas sob modelo multiplicativo, isto é, utilizando log-transformado destas medidas. Os métodos para verificar a bioequivalência média entre T e R foram os intervalos de confiança e os dois testes unilaterais t. Conclui-se, então, que há bioequivalência média entre as duas formulações, baseados nos resultados obtidos pelas análises da isotretinoína e 4-oxo-isotretinoína.
