scholarly journals Ultrasonographic needle tip tracking for in-plane infraclavicular brachialis plexus blocks: a randomized controlled volunteer study

2020 ◽  
Vol 45 (8) ◽  
pp. 634-639
Author(s):  
Trine Kåsine ◽  
Luis Romundstad ◽  
L A Rosseland ◽  
Morten Wang Fagerland ◽  
Paul Kessler ◽  
...  
Keyword(s):  
Primary Outcome ◽  
New Technology ◽  
Onset Time ◽  
Piezoelectric Sensor ◽  
Secondary Outcome ◽  
Procedure Time ◽  
Ultrasound Guided ◽  
Hand Motion ◽  
Randomized Controlled ◽  
Volunteer Study

BackgroundOnvision is a new technology for needle tip detection and tracking in ultrasound-guided regional anesthesia. The system consists of a piezoelectric sensor close to the needle tip and an electronic console integrated in the ultrasound system. The needle tip is visualized by a green circle on the ultrasound screen. The aim of the study was to investigate the effect of the new needle tip tracking technology on in-plane infraclavicular plexus blocks.MethodsThe study was a randomized, controlled, observer blinded cross-over trial in 26 healthy volunteers. Two specialists in anesthesiology performed an ultrasound-guided infraclavicular lateral sagittal brachial plexus block with and without needle tip tracking. Primary outcome was procedure time, measured from insertion of the needle until local anesthesia injection was completed. Secondary outcome measures included the number of hand movements and path lengths (assessed by hand motion analysis), block success rate, onset time and duration, discomfort experienced by the volunteers, and the anesthesiologists’ confidence as to whether their block would be successful or not.ResultsMean (SD) procedure time was 183.0 (56.1) s with and 206.8 (56.2) s without needle tip tracking (p=0.16). There were no significant differences in any of the secondary outcomes. Two volunteers’ experienced Horner syndrome after blocks without needle tip tracking. No other adverse events occurred during the study.ConclusionOur study on needle tip tracking for infraclavicular blocks did not reveal any significant differences between active needle tip tracking and the control procedures, neither for primary outcome nor secondary outcome measurements.Trial registration numberNCT03631914

scholarly journals Ultrasound-Guided Cannulation of the Great Saphenous Vein in Neonates: A Randomized Study

2021 ◽  
Author(s):  
Zhenzhen Tu ◽  
Yanzhe Tan ◽  
Lifei Liu ◽  
Jia Xie ◽  
Ying Xu ◽  
...  
Keyword(s):  
Great Saphenous Vein ◽  
Randomized Study ◽  
Controlled Study ◽  
Control Group ◽  
Success Rates ◽  
Procedure Time ◽  
Ultrasound Guided ◽  
Randomized Controlled ◽  
Key Points ◽  
Procedural Time

Objective This prospective randomized controlled study aimed to compare the ultrasound-guided (USG) technique with the standard single-wall puncture technique for epicutaneo-caval catheter (ECC) placement in neonates. Study Design A total of 100 neonates were included in this study. All enrolled neonates were randomly divided into two groups (n = 50): the USG group and the control group. The control group underwent standard single-wall puncture for ECC placement procedures, and the USG group underwent USG ECC placement procedures. Results The first attempt success rates (62 vs. 38%; p = 0.016) and the total success rates (92 vs. 74%; p = 0.017) were higher in the USG group than in the control group. The procedure time was shorter in the USG group than in the control group: 351.43 (112.95) versus 739.78 seconds (369.13), p < 0.001. The incidence of adverse events was not significantly different between the two groups. Conclusion Compared with the standard single-wall puncture method, USG cannulation is superior for neonatal ECC placement, with a higher success rate, and decreases the total procedural time. Key Points

scholarly journals Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Feng Bin Lin ◽  
◽  
Shi Da Chen ◽  
Yun He Song ◽  
Wei Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intraocular Pressure ◽  
High Myopia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Rank Test ◽  
Inner Plexiform Layer ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Currently, whether and when intraocular pressure (IOP)-lowering medication should be used in glaucoma suspects with high myopia (GSHM) remains unknown. Glaucoma suspects are visual field (VF) defects that cannot be explained by myopic macular changes or other retinal and neurologic conditions. Glaucoma progression is defined by VF deterioration. Here we describe the rationale, design, and methodology of a randomized controlled trial (RCT) designed to evaluate the effects of medically lowering IOP in GSHM (GSHM study). Methods The GSHM study is an open-label, single-center, RCT for GSHM. Overall, 264 newly diagnosed participants, aged 35 to 65 years, will be recruited at the Zhongshan Ophthalmic Center, Sun Yat-sen University, between 2020 and 2021. Participants will be randomly divided into two arms at a 1:1 ratio. Participants in the intervention arm will receive IOP-lowering medication, while participants in the control arm will be followed up without treatment for 36 months or until they reach the end point. Only one eye per participant will be eligible for the study. If both eyes are eligible, the eye with the worse VF will be recruited. The primary outcome is the incidence of glaucoma suspect progression by VF testing over 36 months. The secondary outcomes include the incidence of changes in the optic nerve head morphology including the retinal nerve fiber layer, and retinal ganglion cell-inner plexiform layer loss, progression of myopic maculopathy, visual function loss, and change in the quality of life. Statistical analyses will include baseline characteristics comparison between the intervention and control groups using a two-sample t-test and Wilcoxon rank sum test; generalized linear models with Poisson regression for the primary outcome; Kaplan-Meier curve and log-rank test for the incidence of the secondary outcome; and longitudinal analyses to assess trends in outcomes across time. Discussion To the best of our knowledge, the GSHM study is the first RCT to investigate the impact of medically lowering IOP in GSHM. The results will have implications for the clinical management of GSHM. Trial registration ClinicalTrials.gov NCT04296916. Registered on 4 March 2020

scholarly journals Side Effects of Intravenous Patient-Controlled Analgesia with Remifentanil Compared with Intermittent Epidural Bolus for Labour Analgesia – A Randomized Controlled Trial

PRILOZI ◽  
2019 ◽  
Vol 40 (3) ◽  
pp. 99-108
Author(s):  
Dafina Karadjova ◽  
Mirjana Shosholcheva ◽  
Еmilija Ivanov ◽  
Аtanas Sivevski ◽  
Ivo Kjaev ◽  
...  
Keyword(s):  
Side Effects ◽  
Epidural Analgesia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Patient Controlled Analgesia ◽  
Obstetric Anaesthesia ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Remifentanil Group

Abstract Introduction: Epidural analgesia is considered a gold standard in obstetric anaesthesia and analgesia. However, in situation when it is contraindicated, unwanted by the patient or simply unavailable, remifentanil can be an excellent alternative. The goal of our study is to analyse the side effects of intravenous patient-controlled analgesia (IV PCA) with remifentanil compared with epidural analgesia during delivery. Material and methods: This study included 155 pregnant women in term for birth, divided into 2 groups: a remifentanil group (RG), and an epidural group (EG). Patients in the RG received intravenous PCA with remifentanil, while patients in the ЕG received epidural analgesia with programmed intermittent bolus dosing. Our primary outcome was maternal safety; the secondary outcome was neonatal safety. Results: The results present a significantly lower SaO2 value of the parturients in the RG (96.95 ± 1.4 vs 98.22 ± 0.6), and a significantly higher respiratory rate per minute in the EG at all time points after the onset of analgesia (20.85 ± 1.4 vs 18.67 ± 0.9). There was more frequent sedation, nausea and vomiting in the RG, while in the EG there was a more elevated temperature, itching and irregularities in the CTG record. Regarding the newborn, there was no significant difference between the two groups in the Apgar scores, pH, pCO2, pO2, and bicarbonate, while there was a significantly lower value of the base excess in the RG group. Conclusion: PCA with remifentanil is safe for the mother, foetus and the newborn, with minimal side effects. Continuous respiratory monitoring, oxygen supply and following of all consensus recommendations are mandatory.

scholarly journals Antifungal prophylaxis for prevention of COVID-19-associated pulmonary aspergillosis in critically ill patients: an observational study

Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Stefan Hatzl ◽  
Alexander C. Reisinger ◽  
Florian Posch ◽  
Juergen Prattes ◽  
Martin Stradner ◽  
...  
Keyword(s):  
Observational Study ◽  
Primary Outcome ◽  
Antifungal Prophylaxis ◽  
Secondary Outcome ◽  
Medical Mycology ◽  
Pulmonary Aspergillosis ◽  
Randomized Controlled ◽  
Prophylaxis Group ◽  
Baseline Characteristics ◽  
Propensity Score Adjustment

Abstract Background Coronavirus disease 19 (COVID-19)-associated pulmonary aspergillosis (CAPA) emerged as important fungal complications in patients with COVID-19-associated severe acute respiratory failure (ARF). Whether mould active antifungal prophylaxis (MAFP) can prevent CAPA remains elusive so far. Methods In this observational study, we included all consecutive patients admitted to intensive care units with COVID-19-associated ARF between September 1, 2020, and May 1, 2021. We compared patients with versus without antifungal prophylaxis with respect to CAPA incidence (primary outcome) and mortality (secondary outcome). Propensity score adjustment was performed to account for any imbalances in baseline characteristics. CAPA cases were classified according to European Confederation of Medical Mycology (ECMM)/International Society of Human and Animal Mycoses (ISHAM) consensus criteria. Results We included 132 patients, of whom 75 (57%) received antifungal prophylaxis (98% posaconazole). Ten CAPA cases were diagnosed, after a median of 6 days following ICU admission. Of those, 9 CAPA cases were recorded in the non-prophylaxis group and one in the prophylaxis group, respectively. However, no difference in 30-day ICU mortality could be observed. Thirty-day CAPA incidence estimates were 1.4% (95% CI 0.2–9.7) in the MAFP group and 17.5% (95% CI 9.6–31.4) in the group without MAFP (p = 0.002). The respective subdistributional hazard ratio (sHR) for CAPA incidence comparing the MAFP versus no MAFP group was of 0.08 (95% CI 0.01–0.63; p = 0.017). Conclusion In ICU patients with COVID-19 ARF, antifungal prophylaxis was associated with significantly reduced CAPA incidence, but this did not translate into improved survival. Randomized controlled trials are warranted to evaluate the efficacy and safety of MAFP with respect to CAPA incidence and clinical outcomes.

scholarly journals Reporting and interpretation of results from clinical trials that did not claim a treatment difference

2018 ◽  
Author(s):  
Simon Gates
Keyword(s):  
Primary Outcome ◽  
High Impact ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Treatment Benefit ◽  
Treatment Difference ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Treatment Comparisons ◽  
Randomised Controlled

Objectives: To describe and summarise the reporting of “non-significant” results in randomized controlled trials (RCTs), and to estimate how commonly trial reports make erroneous claims of no treatment difference based on a non-statistically significant result.Design: Retrospective survey of published RCTs.Setting: Four high impact factor general medical journals, published between June 2016 and June 2017.Participants: Reports of randomised controlled trials that did not find a difference between the interventions they compared.Interventions: Not an interventional study.Primary and secondary outcome measures: We recorded the way each trial’s results for its primary outcome or outcomes were described in the Results and Conclusions sections of the Abstract, using a 10-category classification. We estimated the proportion of papers that made claims that were not justified by the results, or were open to multiple interpretations.Results: Eighty-five trial reports were included, reporting 111 treatment comparisons. The majority of papers made unjustified or confusing statements. In the Results section of abstracts, for 55/111 comparisons (49.5%) the study’s results were re-stated, without interpretation, and 34/111 (30.6%) stated that there was not a statistically significant difference. In the conclusions, 61/111 treatment comparisons (55%) stated that there was no treatment benefit, 14/111 (12.6%) that there was no significant benefit, and 13/111 (11.7%) that there was no significant difference. Conclusions: Despite decades of warnings, the error of concluding a lack of treatment benefit from a non-statistically significant result remains common.

scholarly journals 3,4-diaminopyridine Treatment for Lambert-Eaton Myasthenic Syndrome in Adults: A Meta-analysis of Randomized Controlled Trials

2020 ◽  
Author(s):  
Na Zhang ◽  
Daojun Hong ◽  
Taohui Ouyang ◽  
Wei Meng ◽  
Jingwei Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Autoimmune Disorder ◽  
Placebo Treatment ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Compound Muscle Action Potentials ◽  
Myasthenic Syndrome

Abstract Background: Lambert-Eaton myasthenic syndrome (LEMS) is a rare autoimmune disorder of neuromuscular transmission. The objective was to examine the efficacy and safetyof 3,4-diaminopyridine (3,4-DAP) in LEMS. Methods: We searched several databases to identify relevant studies, including PubMed, EMBASE, Cochrane Neuromuscular Disease Group Specialized Register and the Cochrane Controlled Trials Register.The primary outcome Quantitative Myasthenia Gravis (QMG) muscle score and secondary outcome compound muscle action potentials (CMAP) amplitude were pooled by meta-analysis. Results: Six randomised controlled trials (RCT) involving 115 patients with LEMS were included. A meta-analysis of the primary outcome showed a significant improvement of 2.33 (95% CI, -2.81 to -1.85, p<0.001) in QMG muscle score after treatment with 3,4-DAP. Moreover, a meta-analysis of the secondary outcome showed that the overall mean CMAP amplitude improved significantly in LEMS patients with 3, 4-DAP treatment, compared with placebo treatment(mean difference 1.63 mV, 95% CI, 0.85 to 2.41, p<0.001). The overall assessment of all included trials showed low risk of bias and low heterogeneity. Conclusioins: The pooled results demonsrated that 3,4-DAP had a significant effect on LEMS treatment, with improvements in muscle strength score and CMAP amplitude, which are moderate to high evidence from randomized controlled trials.

scholarly journals Comparison of Two Transvenous Temporary Pacemaker Fixation Methods: FIX-IT Trial

2019 ◽  
Vol 32 (2) ◽  
pp. 101-107
Author(s):  
Raoni de Castro Galvão ◽  
Bruno Papelbaum ◽  
Raquel Almeida Lopes Neves ◽  
Fabricio Mantovani Cezar ◽  
Luciene Dias de Jesus ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Total Duration ◽  
Initial Position ◽  
The Other ◽  
Secondary Outcome ◽  
Procedure Time ◽  
Infection Treatment ◽  
Group Data ◽  
Temporary Pacemaker ◽  
Electrode Lead

Introduction: the necessity for a temporary pacemaker (TP) goes through several scenarios. Some patients require the device to complete an infection treatment, regain the pace after myocardial infarction, or while awaiting the release of the definitive device by the health care provider. Regardless of the TP passage technique, good electrode fixation is essential, avoiding dislocation and the necessity for repositioning, among other complications. Objective: to compare two forms of TP fixation, one under direct fixation to the skin and the other keeping the venous introducer connected to the plastic protection through the pacemaker electrode lead. Methods: Forty patients were randomized, 20 in each group. Data regarding the procedure time, electrode lead position, command thresholds, sensitivity, and complications were recorded. The primary outcome considered was the necessity for repositioning or exchange of transvenous TP and secondary any complication without the necessity to reposition it. Results: There were no significant differences in the total duration of the procedure between the groups in the initial position of the electrode and the access route used. The group with plastic protection had a higher primary outcome (60%) than the direct fixation group (20%; p = 0.0098). There were no differences regarding the secondary outcome (p = 1.0). The group with plastic protection also had more total complications compared to the other group (p = 0.0262). Conclusion: Direct fixation of the pacemaker electrode lead was safer concerning the fixation with plastic protection, reducing complications such as electrode dislocation requiring repositioning or replacement without increasing the procedure time.

Platelet-Rich Plasma for Patellar Tendinopathy: A Randomized Controlled Trial of Leukocyte-Rich PRP or Leukocyte-Poor PRP Versus Saline

2019 ◽  
Vol 47 (7) ◽  
pp. 1654-1661 ◽  
Author(s):  
Alex Scott ◽  
Robert F. LaPrade ◽  
Kimberly G. Harmon ◽  
Giuseppe Filardo ◽  
Elizaveta Kon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Patellar Tendinopathy ◽  
Secondary Outcome ◽  
Global Rating ◽  
Ultrasound Guided ◽  
Randomized Controlled ◽  
Significant Difference

Background: A small number of randomized controlled trials have found ultrasound-guided injection of platelet-rich plasma (PRP) to be no more effective than saline for several tendinopathies; limited information exists for patellar tendinopathy. In addition, different PRP formulations that produce varying concentrations of leukocytes have not been directly compared for patellar tendinopathy. Purpose/Hypothesis: To determine if a single ultrasound-guided PRP injection, either leukocyte-rich PRP (LR-PRP) or leukocyte-poor PRP (LP-PRP), was superior to saline injection for the treatment of patellar tendinopathy. The null hypothesis was that no treatment would be superior to another for the treatment of patellar tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Athletes with patellar tendinopathy for ≥6 months (Blazina stage IIIB) were assessed for eligibility in a multisite single-blind controlled trial. There were 3 injection arms: LR-PRP, LP-PRP, and saline. Patients received a single ultrasound-guided injection, followed by 6 weeks of supervised rehabilitation (heavy slow resistance training, concentric and eccentric, 3 times per week). Outcome measures—Victorian Institute of Sport Assessment (patellar; VISA-P), pain during activity, and global rating of change—were assessed at 6 and 12 weeks and 6 and 12 months. VISA-P score at 12 weeks was the primary outcome. Fifty-seven patients (19 in each group) were included in an intention-to-treat analysis. Secondary outcome measures included pain during activity and patients’ global rating of change. Results: Study retention was 93% at 12 weeks and 79% after 1 year. There was no significant difference in mean change in VISA-P score, pain, or global rating of change among the 3 treatment groups at 12 weeks or any other time point. After 1 year, the mean (SD) outcomes for the LR-PRP, LP-PRP, and saline groups were as follows, respectively: VISA-P—58 (29), 71 (20), and 80 (18); pain—4.0 (2.4), 2.4 (2.3), and 2.0 (1.9); global rating of change—4.7 (1.6), 5.6 (1.0), and 5.7 (1.2) ( P > .05 for all outcomes). Conclusion: Combined with an exercise-based rehabilitation program, a single injection of LR-PRP or LP-PRP was no more effective than saline for the improvement of patellar tendinopathy symptoms. Registration: NCT02116946 (ClinicalTrials.gov identifier).

scholarly journals Effectiveness of Self-Help Plus in Preventing Mental Disorders in Refugees and Asylum Seekers in Western Europe: A Multinational Randomized Controlled Trial

2021 ◽  
pp. 1-12
Author(s):  
Marianna Purgato ◽  
Kenneth Carswell ◽  
Federico Tedeschi ◽  
Ceren Acarturk ◽  
Minna Anttila ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mental Disorders ◽  
Asylum Seekers ◽  
Western Europe ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Self Help ◽  
Refugees And Asylum Seekers

<b><i>Introduction:</i></b> Self-Help Plus (SH+) is a group-based psychological intervention developed by the World Health Organization for managing stress. <b><i>Objective:</i></b> To assess the effectiveness of SH+ in preventing mental disorders in refugees and asylum seekers in Western Europe. <b><i>Methods:</i></b> We conducted a randomized controlled trial in 5 European countries. Refugees and asylum seekers with psychological distress (General Health Questionnaire score ≥3), but without a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) or ICD/10 diagnosis of mental disorder, as assessed with the Mini International Neuropsychiatric Interview (MINI), were randomized to SH+ or enhanced treatment as usual (ETAU). The primary outcome was the frequency of mental disorders with the MINI at 6 months. Secondary outcomes included the frequency of mental disorders at postintervention, self-identified problems, psychological symptoms, and other outcomes. <b><i>Results:</i></b> Four hundred fifty-nine individuals were randomly assigned to SH+ or ETAU. For the primary outcome, we found no difference in the frequency of mental disorders at 6 months (Cramer <i>V</i> = 0.007, <i>p</i> = 0.90, RR = 0.96; 95% CI 0.52–1.78), while the difference significantly favored SH+ at after the intervention (secondary outcome, measured within 2 weeks from the last session; Cramer <i>V</i> = 0.13, <i>p</i> = 0.01, RR = 0.50; 95% CI 0.29–0.87). <b><i>Conclusions:</i></b> This is the first randomized indicated prevention study with the aim of preventing the onset of mental disorders in asylum seekers and refugees in Western Europe. As a prevention effect of SH+ was not observed at 6 months, but rather after the intervention only, modalities to maintain its beneficial effect in the long term need to be identified.

Hand motion analysis for assessment of nursing competence in ultrasound-guided peripheral intravenous catheter placement

2018 ◽  
Vol 20 (3) ◽  
pp. 301-306 ◽  
Author(s):  
Ryan J Good ◽  
Kelly K Rothman ◽  
Daniel J Ackil ◽  
John S Kim ◽  
Jonathan Orsborn ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Motion Analysis ◽  
Training Session ◽  
Procedure Time ◽  
Ultrasound Guided ◽  
Intravenous Catheter ◽  
Hand Motion ◽  
Nursing Competence ◽  
Hands On ◽  
Peripheral Intravenous Catheter

Introduction: Objective measures such as hand motion analysis are needed to assess competency in technical skills, including ultrasound-guided procedures. Ultrasound-guided peripheral intravenous catheter placement has many potential benefits and is a viable skill for nurses to learn. The objective of this study was to demonstrate the feasibility and validity of hand motion analysis for assessment of nursing competence in ultrasound-guided peripheral intravenous placement. Methods: We conducted a prospective cohort study at a tertiary children’s hospital. Participants included a convenience sample of nurses with no ultrasound-guided peripheral intravenous experience and experts in ultrasound-guided peripheral intravenous placement. Nurses completed hand motion analysis before and after participating in a simulation-based ultrasound-guided peripheral intravenous placement training program. Experts also completed hand motion analysis to provide benchmark measurements. After training, nurses performed ultrasound-guided peripheral intravenous placement in clinical practice and self-reported details of attempts. Results: A total of 21 nurses and 6 experts participated. Prior to the hands-on training session, experts performed significantly better in all hand motion analysis metrics and procedure time. After completion of the hands-on training session, the nurses showed significant improvement in all hand motion analysis metrics and procedure time. Few nurses achieved hand motion analysis metrics within the expert benchmark after completing the hands-on training session with the exception of angiocatheter motion smoothness. In total, 12 nurses self-reported 38 ultrasound-guided peripheral intravenous placement attempts in clinical practice with a success rate of 60.5%. Discussion: We demonstrated the feasibility and construct validity of hand motion analysis as an objective assessment of nurse competence in ultrasound-guided peripheral intravenous placement. Nurses demonstrated rapid skill acquisition but did not achieve expert-level proficiency.

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