scholarly journals LO43: Does point of care ultrasound improve resuscitation markers in emergency department patients with undifferentiated hypotension? The first Sonography in Hypotension and Cardiac Arrest in the Emergency Department (SHOC-ED 1) Study; an international randomized controlled trial

CJEM ◽  
2017 ◽  
Vol 19 (S1) ◽  
pp. S42
Author(s):  
L. Taylor ◽  
J. Milne ◽  
D. Lewis ◽  
L. Diegelmann ◽  
H. Lamprecht ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Point Of Care ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Volume Of Fluid ◽  
Point Of Care Ultrasound ◽  
Shock Index ◽  
Randomized Controlled ◽  
Significant Difference

Introduction: Point of Care Ultrasound (PoCUS) protocols are commonly used to guide resuscitation for emergency department (ED) patients with undifferentiated non-traumatic hypotension. While PoCUS has been shown to improve early diagnosis, there is a minimal evidence for any outcome benefit. We completed an international multicenter randomized controlled trial (RCT) to assess the impact of a PoCUS protocol on key resuscitation markers in this group. We report diagnostic impact and mortality elsewhere. Methods: The SHoC-ED1 study compared the addition of PoCUS to standard care within the first hour in the treatment of adult patients presenting with undifferentiated hypotension (SBP<100 mmHg or a Shock Index >1.0) with a control group that did not receive PoCUS. Scans were performed by PoCUS-trained physicians. 4 North American, and 3 South African sites participated in the study. Resuscitation outcomes analyzed included volume of fluid administered in the ED, changes in shock index (SI), modified early warning score (MEWS), venous acid-base balance, and lactate, at one and four hours. Comparisons utilized a T-test as well as stratified binomial log-regression to assess for any significant improvement in resuscitation amount the outcomes. Our sample size was powered at 0.80 (α:0.05) for a moderate effect size. Results: 258 patients were enrolled with follow-up fully completed. Baseline comparisons confirmed effective randomization. There was no significant difference in mean total volume of fluid received between the control (1658 ml; 95%CI 1365-1950) and PoCUS groups (1609 ml; 1385-1832; p=0.79). Significant improvements were seen in SI, MEWS, lactate and bicarbonate with resuscitation in both the PoCUS and control groups, however there was no difference between groups. Conclusion: SHOC-ED1 is the first RCT to compare PoCUS to standard of care in hypotensive ED patients. No significant difference in fluid used, or markers of resuscitation was found when comparing the use of a PoCUS protocol to that of standard of care in the resuscitation of patients with undifferentiated hypotension.

scholarly journals Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Paul Drain ◽  
Kenneth Ngure ◽  
Nelly Mugo ◽  
Matthew Spinelli ◽  
Purba Chatterjee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Real Time ◽  
Point Of Care ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Preexposure Prophylaxis ◽  
Adherence Monitoring ◽  
First Time

BACKGROUND The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. OBJECTIVE The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial. METHODS The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair. RESULTS This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020. CONCLUSIONS A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide. CLINICALTRIAL ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/15029

scholarly journals Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission: study protocol of a randomized controlled trial—the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ximena Cid ◽  
David Canty ◽  
Alistair Royse ◽  
Andrea B. Maier ◽  
Douglas Johnson ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Patient Management ◽  
Point Of Care ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Point Of Care Ultrasound ◽  
Randomized Controlled

Abstract Background Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision-making as well as timely intervention for optimal patient management. This makes its utility in patients admitted to internal medicine wards attractive. However, there is still an evidence gap in all the medical setting of how its use affects clinical variables such as length of stay, morbidity, and mortality. Methods/design A prospective randomized controlled trial assessing the effect of a surface POCUS of the heart, lungs, and femoral and popliteal veins performed by an internal medicine physician during the first 24 h of patient admission to the unit with a presumptive cardiopulmonary diagnosis. The University of Melbourne iHeartScan, iLungScan, and two-point venous compression protocols are followed to identify left and right ventricular function, significant valvular heart disease, pericardial and pleural effusion, consolidation, pulmonary edema, pneumothorax, and proximal deep venous thrombosis. Patient management is not commanded by the protocol and is at the discretion of the treating team. A total of 250 patients will be recruited at one tertiary hospital. Participants are randomized to receive POCUS or no POCUS. The primary outcome measured will be hospital length of stay. Secondary outcomes include the change in diagnosis and management, 30-day hospital readmission, and healthcare costs. Discussion This study will evaluate the clinical impact of multi-organ POCUS in internal medicine patients admitted with cardiopulmonary diagnosis on the hospital length of stay. Recruitment of participants commenced in September 2018 and is estimated to be completed by March 2020. Trial registration Australian and New Zealand Clinical Trial Registry, ACTRN12618001442291. Registered on 28 August 2018.

scholarly journals Randomized controlled trial of emergency department initiated smoking cessation counselling and referral to a community counselling service

CJEM ◽  
2017 ◽  
Vol 20 (4) ◽  
pp. 556-564 ◽  
Author(s):  
Ka Wai Cheung ◽  
Ian WH. Wong ◽  
Warren Fingrut ◽  
Amy Po Yu Tsai ◽  
Sally R. Ke ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Controlled Trial ◽  
Intervention Group ◽  
Counselling Service ◽  
Randomized Controlled ◽  
Smoking Cessation Counselling ◽  
Significant Difference ◽  
Community Counselling

AbstractObjectiveWorldwide, tobacco smoke is still the leading cause of preventable morbidity and mortality. Many smokers develop chronic smoking-related conditions that require emergency department (ED) visits. However, best practices for ED smoking cessation counselling are still unclear.MethodsA randomized controlled trial was conducted to determine whether an “ask, advise, and refer” approach increases 12-month, 30-day quit rates in the stable adult ED smoking population compared to usual care. Patients in the intervention group were referred to a community counselling service that offers a quitline, a text-based program, and a Web-based program. Longitudinal intention-to-treat analyses were performed.ResultsFrom November 2011 to March 2013, 1,295 patients were enrolled from one academic tertiary care ED. Six hundred thirty-five were allocated to usual care, and 660 were allocated to intervention. Follow-up data were available for 70% of all patients at 12 months. There was no statistically significant difference in 12-month, 30-day quit rates between the two groups. However, there was a trend towards higher 7-day quit attempts, 7-day quit rates, and 30-day quit rates at 3, 6, and 12 months in the intervention group.ConclusionIn this study, there was a trend towards increased smoking cessation following referral to a community counselling service. There was no statistically significant difference. However, if ED smoking cessation efforts were to provide even a small positive effect, such an intervention may have a significant public health impact given the extensive reach of emergency physicians.

scholarly journals Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission. – Study protocol of a randomized controlled trial: the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study

2019 ◽  
Author(s):  
Ximena Anaite Cid ◽  
David Canty ◽  
Alistair Royse ◽  
Andrea Maier ◽  
Douglas Johnson ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Patient Management ◽  
Point Of Care ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Point Of Care Ultrasound ◽  
Randomized Controlled

Abstract Background Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision making, and timely intervention for optimal patient management. This makes its utility in patients admitted to internal medicine wards attractive. However, there is still an evidence gap in all the medical setting of how its use affects clinical variables such as length of stay, morbidity and mortality. Methods/design A prospective randomized controlled trial assessing the effect of a surface POCUS of the heart, lungs, and femoral and popliteal veins performed by an internal medicine physician during the first 24 hours of patient admission to the unit with a presumptive cardiopulmonary diagnosis. The University of Melbourne iHeartScan, iLungScan and 2-point venous compression protocols are followed to identify left and right ventricular function, significant valvular heart disease, pericardial and pleural effusion, consolidation, pulmonary edema, pneumothorax and proximal deep venous thrombosis. Patient management is not commanded by the protocol and is at the discretion of the treating team. A total of 250 patients will be recruited at one tertiary hospital. Participants are randomized to receive POCUS or no POCUS. The primary outcome measured will be hospital length of stay. Secondary outcomes include the change in diagnosis and management, 30-day hospital readmission and health care costs. Discussion This study will evaluate the clinical impact of multi-organ POCUS in internal medicine patients admitted with cardiopulmonary diagnosis on the hospital length of stay. Recruitment of participants has commenced in September of 2018 and is estimated to be completed by March 2020.

scholarly journals LO45: Does the use of point of care ultrasonography improve survival in emergency department patients with undifferentiated hypotension? The first Sonography in Hypotension and Cardiac Arrest in the Emergency Department (SHOC-ED1) Study; an international randomized controlled trial

CJEM ◽  
2017 ◽  
Vol 19 (S1) ◽  
pp. S43
Author(s):  
P.R. Atkinson ◽  
J. Milne ◽  
L. Diegelmann ◽  
H. Lamprecht ◽  
M. Stander ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Diagnostic Accuracy ◽  
Standard Care ◽  
Primary Outcome ◽  
Point Of Care ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Secondary Outcomes

Introduction: Point of care ultrasound (PoCUS) is an established tool in the initial management of patients with undifferentiated hypotension in the emergency department (ED). While PoCUS protocols have been shown to improve early diagnostic accuracy, there is little published evidence for any mortality benefit. We report the findings from our international multicenter randomized controlled trial, assessing the impact of a PoCUS protocol on survival and key clinical outcomes. Methods: Recruitment occurred at 7 centres in North America (4) and South Africa (3). Scans were performed by PoCUS-trained physicians. Screening at triage identified patients (SBP<100 or shock index>1), randomized to PoCUS or control (standard care and no PoCUS) groups. Demographics, clinical details and study findings were collected prospectively. Initial and secondary diagnoses were recorded at 0 and 60 minutes, with ultrasound performed in the PoCUS group prior to secondary assessment. The primary outcome measure was 30-day/discharge mortality. Secondary outcome measures included diagnostic accuracy, changes in vital signs, acid-base status, and length of stay. Categorical data was analyzed using Fishers test, and continuous data by Student T test and multi-level log-regression testing. (GraphPad/SPSS) Final chart review was blinded to initial impressions and PoCUS findings. Results: 258 patients were enrolled with follow-up fully completed. Baseline comparisons confirmed effective randomization. There was no difference between groups for the primary outcome of mortality; PoCUS 32/129 (24.8%; 95% CI 14.3-35.3%) vs. Control 32/129 (24.8%; 95% CI 14.3-35.3%); RR 1.00 (95% CI 0.869 to 1.15; p=1.00). There were no differences in the secondary outcomes; ICU and total length of stay. Our sample size has a power of 0.80 (α:0.05) for a moderate effect size. Other secondary outcomes are reported separately. Conclusion: This is the first RCT to compare PoCUS to standard care for undifferentiated hypotensive ED patients. We did not find any mortality or length of stay benefits with the use of a PoCUS protocol, though a larger study is required to confirm these findings. While PoCUS may have diagnostic benefits, these may not translate into a survival benefit effect.

scholarly journals Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial

10.2196/15029 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e15029
Author(s):  
Paul Drain ◽  
Kenneth Ngure ◽  
Nelly Mugo ◽  
Matthew Spinelli ◽  
Purba Chatterjee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Real Time ◽  
Point Of Care ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Preexposure Prophylaxis ◽  
Adherence Monitoring ◽  
First Time

Background The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. Objective The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial. Methods The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair. Results This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020. Conclusions A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide. Trial Registration ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464 International Registered Report Identifier (IRRID) PRR1-10.2196/15029

Point-of-care ultrasound before attempting clean-catch urine collection in infants: a randomized controlled trial

CJEM ◽  
2019 ◽  
Vol 21 (5) ◽  
pp. 646-652 ◽  
Author(s):  
Olivia Weill ◽  
Mélanie Labrosse ◽  
Arielle Levy ◽  
Marie Pier Desjardins ◽  
Evelyne D. Trottier ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Success Rate ◽  
Point Of Care ◽  
Controlled Trial ◽  
Point Of Care Ultrasound ◽  
Urine Collection ◽  
Feeding Period ◽  
Randomized Controlled ◽  
Feeding Group ◽  
Stimulation Technique

ABSTRACTObjectiveA new non-invasive bladder stimulation technique has been described to obtain clean-catch urine specimens in infants. This study aimed to evaluate if point-of-care ultrasound (POCUS) guided feeding protocol to measure bladder volume prior to stimulation techniques improves clean-catch urine collection success.MethodsA prospective randomized controlled trial study was conducted in a tertiary care pediatric emergency department. Infants aged less than 6 months needing a urine sample were randomized to either POCUS group or feeding group (standard procedure) before performing a standardized clean-catch urine stimulation technique. In the POCUS group, a feeding period was permitted if the bladder width was less than 2 cm, otherwise the clean-catch urine was performed immediately. The primary outcome was the success of the procedure defined by the collection of at least 2 mL of urine, obtained within 300 seconds of bladder stimulation manoeuvres. It was estimated that the recruitment of 200 children was necessary to yield 80% power to identify an improvement of 20% in the success rate.ResultsA total of 201 infants were included. The procedure was not more successful in the POCUS group (48%) compared to the feeding group (54%) (Difference: 6.5%; 95% CI: -7.3 to 19.8%). The mean time to collect urine samples from randomization to sample collection was not different between the two groups.ConclusionsOur study failed to show a benefit of using POCUS to improve the success rate of stimulated clean-catch urine. Moreover, the importance of the feeding period prior to clean-catch urine manoeuvres should be evaluated further.Clinical Trial RegistrationNCT02751671

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