scholarly journals Strengthening the success rate of suprapubic aspiration in infants by integrating point-of-care ultrasonography guidance: A parallel-randomized clinical trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254703
Author(s):  
Sadroddin Mahdipour ◽  
Seyedeh Nastaran Seyed Saadat ◽  
Hamidreza Badeli ◽  
Afagh Hassanzadeh Rad
Keyword(s):  
Clinical Trial ◽  
Success Rate ◽  
Randomized Clinical Trial ◽  
Severe Pain ◽  
Point Of Care ◽  
Diagnostic Methods ◽  
Secondary Outcome ◽  
Point Of Care Ultrasound ◽  
Urine Sampling ◽  
Neonates And Infants

Background Urinary tract infection (UTI) is a common disease in childhood. A sterile collection of urine samples using suprapubic aspiration (SPA) and bladder catheterization (BC) is helpful for rapid and accurate diagnosis of UTI in infants. With the advent of point-of-care ultrasound (POCUS), the use of ultrasound by non-radiologists at the patient’s bedside, great advancement has been noticed in various medical fields. Considering the importance and advantages of using POCUS in the physical examination and guiding procedures, the authors aimed to compare urine sampling’s success rate by SPA, BC, and POCUS guided SPA (POCUS-SPA) in infants performed by three pediatricians. Materials and methods This study is a randomized clinical trial conducted on 114 neonates and infants with suspected UTI admitted to 17-Shahrivar children’s hospital from April 2017 to September 2019. Neonates and infants were randomly assigned to three groups of BC, SPA, and POCUS-SPA. The primary outcome was the success of sampling defined by obtaining 1cc of urine in each method. The secondary outcome was assessing the pain level. Results Results showed that the POCUS-SPA had the highest success rate in urine sampling, and a statistically significant relation was noted among the three groups (P = 0.0001). From 38 patients in each group, 37 patients of POCUS-SPA (97.4%), 34 patients of BC (89.5%), and 23 patients of SPA (60.5%) had a successful sampling. Most of the patients in all three groups experienced severe pain. Conclusions In the current study, results showed that the POCUS-SPA significantly increased the success rate of urine sampling and most of the patients in all three groups had severe pain. Based on the shortage of access to radiologists in emergency setups, it seems that the POCUS-SPA by the pediatricians can be one of the most appropriate and applicable diagnostic methods in infants with UTI.

Convergence Insufficiency Treatment Trial – Attention and Reading Trial (CITT-ART): Design and Methods

2015 ◽  
pp. 214-228 ◽  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Health Care Providers ◽  
Developmental Disorders ◽  
Attention Problems ◽  
Secondary Outcome ◽  
Care Providers ◽  
Treatment Trial ◽  
Additional Hypothesis ◽  
Convergence Insufficiency

Objective: To describe the design and methodology of the Convergence Insufficiency Treatment Trial: Attention and Reading Trial (CITT-ART), the first randomized clinical trial evaluating the effect of vision therapy on reading and attention in school-age children with symptomatic convergence insufficiency (CI). Methods: CITT-ART is a multicenter, placebo-controlled, randomized clinical trial of 324 children ages 9 to 14 years in grades 3 to 8 with symptomatic CI. Participants are randomized to 16 weeks of office-based vergence/accommodative therapy (OBVAT) or placebo therapy (OBPT), both supplemented with home therapy. The primary outcome measure is the change in the Wechsler Individual Achievement Test-Version 3 (WIAT-III) reading comprehension subtest score. Secondary outcome measures are changes in attention as measured by the Strengths and Weaknesses of Attention (SWAN) as reported by parents and teachers, tests of binocular visual function, and other measures of reading and attention. The long-term effects of treatment are assessed 1 year after treatment completion. All analyses will test the null hypothesis of no difference in outcomes between the two treatment groups. The study is entering its second year of recruitment. The final results will contribute to a better understanding of the relationship between the treatment of symptomatic CI and its effect on reading and attention. Conclusion: The study will provide an evidence base to help parents, eye professionals, educators, and other health care providers make informed decisions as they care for children with CI and reading and attention problems. Results may also generate additional hypothesis and guide the development of other scientific investigations of the relationships between visual disorders and other developmental disorders in children.

scholarly journals Effectiveness of Acromioclavicular Joint Mobilization and Physical Therapy vs Physical Therapy Alone in Patients with Frozen Shoulder: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Mohammad Rahbar ◽  
Sepideh Ranjbar Kiyakalayeh ◽  
Bina Eftekharsadat ◽  
Behzad Izadseresht ◽  
Neda Dolatkhah
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Randomized Clinical Trial ◽  
Shoulder Pain ◽  
Acromioclavicular Joint ◽  
Frozen Shoulder ◽  
Secondary Outcome ◽  
Control Group ◽  
Joint Mobilization ◽  
Active Abduction

Abstract Background: Frozen shoulder (FS) is a prevalent musculoskeletal condition characterized by an often prolonged pain, disability and limited active and passive range of motion (ROM), however its management remains challenging yet. The objective of this trial was to compare the efficacy of acromioclavicular joint mobilization and physical therapy versus physical therapy in treatment of FS.Methods: In this single-blind randomized clinical trial, patients with diagnosis of FS were randomly allocated into mobilization + physical therapy (n=28) as experiment group, and physical therapy (n=28) as control group in two outpatient clinics of Tabriz University of Medical Sciences, Iran. The primary outcomes were self-reported shoulder pain-related disability measured by the Shoulder Pain and Disability Index (SPADI) questionnaire and goniometric assessment of shoulder ROM. The secondary outcome was the Visual Analogue Scale (VAS). Measures were performed at the baseline, immediately and one month after beginning the treatments.Results: Totally 51 patients with 25.73 ± 6.88 years old of age completed the study and their data were analyzed. VAS, SPADI, pain and disability improved more significantly in experiment group compared to control group immediately [-4.63 (-5.58- -3.67) vs. -2.22 (-2.96- -1.47), p<0.001; -23.08 (-28.63- -17.53) vs. -13.04 (-17.93- -8.16), p=0.008; -26.00 (-31.71- -20.29) vs. -16.35 (-23.39- -9.31), p=0.034 and -21.25 (-29.11- -13.39) vs. -10.98 (-17.53- -4.43), p=0.042, respectively] and one month after beginning of treatment [-5.58 (-6.45- -4.72) vs. -3.61 (-4.60- -2.62), p<0.001; -33.43 (-40.85- -26.01) vs. -20.03 (-26.00- -14.07), p=0.001; --42.83 (-49.09- -36.57) vs. -25.57 (-33.92- -17.21), p<0.001 and -27.55 (-36.19- -15.94) vs. -16.58 (-24.48- -8.67), p=0.041, respectively]. Active abduction ROM was also improved more significantly immediately after treatment in experiment group compared to control group [25.83 (11.45- 40.13) vs. 10.17 (1.02- 19.15), p=0.025], however there were no significant differences between two groups concerning other measured ROMs immediately and one month after treatment (all p>0.05). Conclusions: Acromioclavicular mobilization along with conventional physical therapy was more efficient in decreasing pain and disability and improving active abduction ROM compared to physical therapy in patients with FS. These findings would suggest a new therapeutic method for shoulder disorders with pain and disability.Trial registrationwww.irct.ir, IRCT20100605004104N7, registered 06.01.2019 (https://www.irct.ir/trial/35900)

scholarly journals Effectiveness of Ginger in the Treatment of Type 2 Diabetes Mellitus: A Pilot Study of the Randomized Clinical Trial Type

Aquichan ◽  
2021 ◽  
Vol 21 (1) ◽  
pp. 1-14
Author(s):  
Gerdane Celene Nunes Carvalho ◽  
Jose Claudio Garcia Lira Neto ◽  
Lívio César Cunha Nunes ◽  
Ana Maria Parente Garcia Alencar ◽  
Regina Lúcia Lino Marques ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Clinical Trial ◽  
Type 2 Diabetes Mellitus ◽  
Pilot Study ◽  
Randomized Clinical Trial ◽  
Trial Type ◽  
Secondary Outcome ◽  
Lipid Levels

Objective: To analyze the effectiveness of ginger in the reduction of the glycemic, lipid and anthropometric levels in people with Type 2 Diabetes Mellitus. Materials and method: A double-blind pilot study of the randomized clinical trial type, conducted between October 2017 and January 2018. The inclusion criteria were as follows: individuals with type 2 diabetes, aged from 18 to 80 years old, using oral antidiabetic drugs, and with glycated hemoglobin values between 7 % and 10 %. The participants were randomized and allocated in two different groups. In the experimental group, the participants used 1.2 g of ginger and, in the control group, 1.2 g of placebo. The primary outcome was the reduction in blood glucose. The reduction in the lipid and anthropometric levels was the secondary outcome. The intervention lasted four weeks. Results: A total of 21 participants were included in the study. The use of 1.2 g of ginger resulted in noticeable reductions in the anthropometric and lipid levels in 30 days of follow-up, but it did not reduce the glycemic levels. Conclusions: In this study, it was shown that ginger capsules, in doses of 1.2 g a day, can help to reduce anthropometric measures and lipid levels in the population under study; however, it had no effect on the glycemic levels.

Insights from the axillary vein puncture guided by ultrasound versus cephalic vein dissection trial

2021 ◽  
Author(s):  
Ana Paula Tagliari ◽  
Adriano Nunes Kochi ◽  
Rodrigo Petersen Saadi ◽  
Bernardo Mastella ◽  
Eduardo Keller Saadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Success Rate ◽  
Randomized Clinical Trial ◽  
Cephalic Vein ◽  
Axillary Vein ◽  
Ultrasound Guided ◽  
Procedural Time

Axillary vein puncture guided by ultrasound (US-Ax) versus cephalic vein dissection in pacemaker and defibrillator implant: a multicenter randomized clinical trial is a recently published study in which 88 patients were randomized in a 1:1 fashion to one of the two methods. Even being performed by operators with not previous ultrasound-guided axillary vein puncture experience, this group presented a higher success rate, lower procedural time and comparable complication incidence.

Impact of a 4-hour Introductory eFAST Training Intervention Among Ultrasound-Naïve U.S. Military Medics

2020 ◽  
Vol 185 (5-6) ◽  
pp. e601-e608
Author(s):  
Jonathan D Monti ◽  
Michael D Perreault
Keyword(s):  
Outcome Measures ◽  
Point Of Care ◽  
Resident Physician ◽  
Secondary Outcome ◽  
Training Intervention ◽  
Point Of Care Ultrasound ◽  
Trauma Patients ◽  
Didactic Training ◽  
Combat Casualty ◽  
The Impact

Abstract Introduction Advances in the portability of ultrasound have allowed it to be increasingly employed at the point of care in austere settings. Battlefield constraints often limit the availability of medical officers throughout the operational environment, leading to increased interest in whether highly portable ultrasound devices can be employed by military medics to enhance their provision of combat casualty care. Data evaluating optimal training for effective medic employment of ultrasound is limited however. This prospective observational cohort study’s primary objective was to assess the impact of a 4-hour introductory training intervention on ultrasound-naïve military medic participants’ knowledge/performance of the eFAST application. Materials and Methods Conventional U.S. Army Medics, all naïve to ultrasound, were recruited from across JBLM. Volunteer participants underwent baseline eFAST knowledge assessment via a 50-question multiple-choice exam. Participants were then randomized to receive either conventional, expert-led classroom didactic training or didactic training via an online, asynchronously available platform. All participants then underwent expert-led, small group hands-on training and practice. Participants’ eFAST performance was then assessed with both live and phantom models, followed by a post-course knowledge exam. Concurrently, emergency medicine (EM) resident physician volunteers, serving as standard criterion for trained personnel, underwent the same OSCE assessments, followed by a written exam to assess their baseline eFAST knowledge. Primary outcome measures included (1) post-course knowledge improvement, (2) eFAST exam technical adequacy, and (3) eFAST exam OSCE score. Secondary outcome measures were time to exam completion and diagnostic accuracy rate for hemoperitoneum and hemopericardium. These outcome measures were then compared across medic cohorts and to those of the EM resident physician cohort. Results A total of 34 medics completed the study. After 4 hours of ultrasound training, overall eFAST knowledge among the 34 medics improved from a baseline mean of 27% on the pretest to 83% post-test. For eFAST exam performance, the medics scored an average of 20.8 out of a maximum of 22 points on the OSCE. There were no statistically significant differences between the medics who received asynchronous learning versus traditional classroom-based learning, and the medics demonstrated comparable performance to previously trained EM resident physicians. Conclusions A 4-hour introductory eFAST training intervention can effectively train conventional military medics to perform the eFAST exam. Online, asynchronously available platforms may effectively mitigate some of the resource requirement burden associated with point-of-care ultrasound training. Future studies evaluating medic eFAST performance on real-world battlefield trauma patients are needed. Skill and knowledge retention must also be assessed for this degradable skill to determine frequency of refresher training when not regularly performed.

Single-access ultrasound-guided tunneled femoral lines in critically ill pediatric patients

2020 ◽  
Vol 21 (6) ◽  
pp. 1034-1041 ◽  
Author(s):  
Andrew Woerner ◽  
Jesse L Wenger ◽  
Eric J Monroe
Keyword(s):  
Critically Ill ◽  
Pediatric Patients ◽  
Point Of Care ◽  
Pediatric Population ◽  
Central Venous Access ◽  
Venous Access ◽  
Point Of Care Ultrasound ◽  
Ultrasound Guided ◽  
Patient Transport ◽  
Neonates And Infants

Central venous access is an essential aspect of critical care for pediatric patients. In the critically ill pediatric population, image-guided procedures performed at the bedside expedite care and may reduce risks and logistical challenges associated with patient transport to a remote procedure suite such as interventional radiology. We describe our institutional technique for ultrasound-guided tunneled femoral venous access in neonates and infants and provide technical pearls from our experience, with an intended audience including specialists performing point-of-care ultrasound–guided procedures as well as interventional radiologist making their services available in the intensive care unit.

scholarly journals A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Brendan P. Jacka ◽  
Jacqueline E. Goldman ◽  
Jesse L. Yedinak ◽  
Edward Bernstein ◽  
Scott E. Hadland ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Behavior Change ◽  
Randomized Clinical Trial ◽  
Study Protocol ◽  
Test Strip ◽  
Health Concern ◽  
Secondary Outcome ◽  
Opioid Overdose ◽  
Test Strips

Abstract Background Opioid overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl, remain a substantial public health concern in North America. Responses to overdose events (e.g., administration of naloxone and rescue breathing) are effective at reducing mortality; however, more interventions are needed to prevent overdoses involving illicitly manufactured fentanyl. This study protocol aims to evaluate the effectiveness of a behavior change intervention that incorporates individual counseling, practical training in fentanyl test strip use, and distribution of fentanyl test strips for take-home use among people who use drugs. Methods Residents of Rhode Island aged 18–65 years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n = 500) will be recruited through advertisements and targeted street-based outreach into a two-arm randomized clinical trial with 12 months of post-randomization follow-up. Eligible participants will be randomized (1:1) to receive either the RAPIDS intervention (i.e., fentanyl-specific overdose education, behavior change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use) or standard overdose education as control. Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization. All participants will be offered naloxone at enrolment. The primary outcome is a composite measure of self-reported overdose in the previous month at 6- and/or 12-month follow-up visit. Secondary outcome measures include administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalization or emergency medical service utilization) overdoses. Discussion If the RAPIDS intervention is found to be effective, its brief MI and fentanyl test strip training components could be easily incorporated into existing community-based overdose prevention programming to help reduce the rates of fentanyl-related opioid overdose. Trial registration ClinicalTrials.gov NCT04372238. Registered on 01 May 2020

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