scholarly journals LO22: Does point-of-care ultrasonography improve diagnostic accuracy in emergency department patients with undifferentiated hypotension? An international randomized controlled trial from the SHoC-ED investigators

CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S15
Author(s):  
P. Atkinson ◽  
M. Peach ◽  
S. Hunter ◽  
A. Kanji ◽  
L. Taylor ◽  
...  

Introduction: Point of care ultrasound has been reported to improve diagnosis in non-traumatic hypotensive ED patients. We compared diagnostic performance of physicians with and without PoCUS in undifferentiated hypotensive patients as part of an international prospective randomized controlled study. The primary outcome was diagnostic performance of PoCUS for cardiogenic vs. non-cardiogenic shock. Methods: SHoC-ED recruited hypotensive patients (SBP < 100 mmHg or shock index > 1) in 6 centres in Canada and South Africa. We describe previously unreported secondary outcomes relating to diagnostic accuracy. Patients were randomized to standard clinical assessment (No PoCUS) or PoCUS groups. PoCUS-trained physicians performed scans after initial assessment. Demographics, clinical details and findings were collected prospectively. Initial and secondary diagnoses including shock category were recorded at 0 and 60 minutes. Final diagnosis was determined by independent blinded chart review. Standard statistical tests were employed. Sample size was powered at 0.80 (α:0.05) for a moderate difference. Results: 273 patients were enrolled with follow-up for primary outcome completed for 270. Baseline demographics and perceived category of shock were similar between groups. 11% of patients were determined to have cardiogenic shock. PoCUS had a sensitivity of 80.0% (95% CI 54.8 to 93.0%), specificity 95.5% (90.0 to 98.1%), LR+ve 17.9 (7.34 to 43.8), LR-ve 0.21 (0.08 to 0.58), Diagnostic OR 85.6 (18.2 to 403.6) and accuracy 93.7% (88.0 to 97.2%) for cardiogenic shock. Standard assessment without PoCUS had a sensitivity of 91.7% (64.6 to 98.5%), specificity 93.8% (87.8 to 97.0%), LR+ve 14.8 (7.1 to 30.9), LR- of 0.09 (0.01 to 0.58), Diagnostic OR 166.6 (18.7 to 1481) and accuracy of 93.6% (87.8 to 97.2%). There was no significant difference in sensitivity (-11.7% (-37.8 to 18.3%)) or specificity (1.73% (-4.67 to 8.29%)). Diagnostic performance was also similar between other shock subcategories. Conclusion: As reported in other studies, PoCUS based assessment performed well diagnostically in undifferentiated hypotensive patients, especially as a rule-in test. However performance was similar to standard (non-PoCUS) assessment, which was excellent in this study.

CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S32
Author(s):  
P. Atkinson ◽  
S. Hunter ◽  
M. Peach ◽  
L. Taylor ◽  
A. Kanji ◽  
...  

Introduction: Although use of point of care ultrasound (PoCUS) protocols for patients with undifferentiated hypotension in the Emergency Department (ED) is widespread, our previously reported SHoC-ED study showed no clear survival or length of stay benefit for patients assessed with PoCUS. In this analysis, we examine if the use of PoCUS changed fluid administration and rates of other emergency interventions between patients with different shock types. The primary comparison was between cardiogenic and non-cardiogenic shock types. Methods: A post-hoc analysis was completed on the database from an RCT of 273 patients who presented to the ED with undifferentiated hypotension (SBP <100 or shock index > 1) and who had been randomized to receive standard care with or without PoCUS in 6 centres in Canada and South Africa. PoCUS-trained physicians performed scans after initial assessment. Shock categories and diagnoses recorded at 60 minutes after ED presentation, were used to allocate patients into subcategories of shock for analysis of treatment. We analyzed actual care delivered including initial IV fluid bolus volumes (mL), rates of inotrope use and major procedures. Standard statistical tests were employed. Sample size was powered at 0.80 (α:0.05) for a moderate difference. Results: Although there were expected differences in the mean fluid bolus volume between patients with non-cardiogenic and cardiogenic shock, there was no difference in fluid bolus volume between the control and PoCUS groups (non-cardiogenic control 1878 mL (95% CI 1550 – 2206 mL) vs. non-cardiogenic PoCUS 1687 mL (1458 – 1916 mL); and cardiogenic control 768 mL (194 – 1341 mL) vs. cardiogenic PoCUS 981 mL (341 – 1620 mL). Likewise there were no differences in rates of inotrope administration, or major procedures for any of the subcategories of shock between the control group and PoCUS group patients. The most common subcategory of shock was distributive. Conclusion: Despite differences in care delivered by subcategory of shock, we did not find any significant difference in actual care delivered between patients who were examined using PoCUS and those who were not. This may help to explain the previously reported lack of outcome difference between groups.


CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S43-S44 ◽  
Author(s):  
L. Richardson ◽  
O. Loubani ◽  
P. Atkinson

Introduction: Undifferentiated hypotension remains one of the most life-threatening presentations to emergency departments (ED) around the world. An accurate and rapid initial assessment is essential, as shock carries a high mortality with multiple unique etiologies and management plans. Point of care ultrasound (PoCUS) has emerged as a promising tool to improve these diagnostic and management challenges, yet its reliability in this setting remains unclear. Methods: We performed a systematic review of Medline, EMBASE, CINAHL, Cochrane, and clinicaltrials.gov databases from inception to June 8, 2018. Databases were reviewed by two independent researchers and all languages were included. The methodological quality of included studies were evaluated using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Our primary outcome was diagnostic accuracy of PoCUS in hypotension, with secondary outcomes including patient outcomes and changes to management. Results: Our literature search revealed 5345 articles after duplicates were removed, leaving 235 articles for full article review. Following full article review, 9 studies remained and were included in the systematic review. There were 2 randomized control trials, 6 prospective cohort trials, and 1 retrospective cohort trial. For our primary outcome of diagnostic accuracy, eight studies were included; we extracted Kappa values ranging from 0.70 to 0.971, pooled sensitivity ranging from 69% to 88%, and pooled specificity ranging from 88% to 96%. Four studies reported on management change including results reporting shorter time to disposition, change in diagnostic test ordering (18% to 31%), change in consultation (13.6%), change in admission location (12%) and change in management plan (25% to 40%). Only one study reported on patient outcomes, which revealed no survival or length of stay benefit. Conclusion: When assessing for the diagnostic accuracy of PoCUS in the setting of undifferentiated hypotension presenting to the emergency department, we found fair consistency between PoCUS and final diagnosis with high Kappa values, fair to good pooled sensitivities, and good to excellent specificities. There was no strong evidence indicating improved outcomes. However, the large amount of heterogeneity amongst studies has limited our ability to make a strong conclusion except that future research should focus on a uniform study design and patient focused outcomes.


CJEM ◽  
2017 ◽  
Vol 19 (S1) ◽  
pp. S43
Author(s):  
P.R. Atkinson ◽  
J. Milne ◽  
L. Diegelmann ◽  
H. Lamprecht ◽  
M. Stander ◽  
...  

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.


CJEM ◽  
2017 ◽  
Vol 19 (S1) ◽  
pp. S42
Author(s):  
L. Taylor ◽  
J. Milne ◽  
D. Lewis ◽  
L. Diegelmann ◽  
H. Lamprecht ◽  
...  

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.


2020 ◽  
Vol 35 (6) ◽  
pp. 632-637
Author(s):  
Cecil J. Simmons ◽  
Lisa D. Mack ◽  
Aaron J. Cronin ◽  
Jonathan D. Monti ◽  
Michael D. Perreault ◽  
...  

AbstractObjective:On-scene prehospital conditions and patient instability may warrant a during-transport ultrasound (US) exam. The objective of this study was to assess the effect of ambulance turbulence on the performance of the Focused Assessment with Sonography in Trauma (FAST) with a handheld US device.Methods:This was a randomized controlled trial in which participants were randomized to perform a FAST in either a stationary or an in-motion military ambulance. Participants were physicians and physician assistants (PAs) with previous FAST training. All exams were performed on an US phantom model. The primary outcome was FAST completion time, reported as a mean, in seconds. Secondary outcomes included image acquisition score (range of 0-24, reported as a mean), diagnostic accuracy (reported as sensitivity and specificity), and a post-participation survey with five-item Likert-type scales.Results:Twenty-seven participants performed 27 FASTs, 14 in the stationary ambulance and 13 in the in-motion ambulance. All participants obtained the four requisite views of the FAST. A significant difference was detected in image acquisition scores in favor of the stationary ambulance group (19.4 versus 16.7 [95% CI for difference, 0.9-4.4]; P <.01). Significant differences in survey items between groups were related to obtaining and maintaining US images and the exam conditions. There was not a difference in FAST completion time between groups (98.5 seconds versus 78.7 seconds [95% CI for difference, -13.5 seconds to 53.1 seconds]; P = .23). Sensitivity and specificity of FAST in the stationary ambulance was 85.7% (95% CI, 67.3%-96.0%) and 96.4% (95% CI, 81.7%-99.9%) versus 96.2% (95% CI, 80.4%-99.9%) and 100.0% (95% CI, 86.8%-100.0%) in the in-motion ambulance group (P = .21).Conclusion:Vehicular motion did not affect FAST completion time and diagnostic accuracy; however, it did reduce FAST image acquisition scores. The results suggest timely and diagnostically accurate FASTs may be completed by experienced sonographers during moderate levels of ambulance turbulence. Further investigation assessing the utility and limitations of newer handheld US devices in various prehospital conditions is warranted.


Cardiology ◽  
2020 ◽  
pp. 1-8
Author(s):  
Ronny Alcalai ◽  
Boris Varshisky ◽  
Ahmad Marhig ◽  
David Leibowitz ◽  
Larissa Kogan-Boguslavsky ◽  
...  

<b><i>Background:</i></b> Early and accurate diagnosis of acute coronary syndrome (ACS) is essential for initiating lifesaving interventions. In this article, the diagnostic performance of a novel point-of-care rapid assay (SensAheart<sup>©</sup>) is analyzed. This assay qualitatively determines the presence of 2 cardiac biomarkers troponin I and heart-type fatty acid-binding protein that are present soon after onset of myocardial injury. <b><i>Methods:</i></b> We conducted a prospective observational study of consecutive patients who presented to the emergency department with typical chest pain. Simultaneous high-sensitive cardiac troponin T (hs-cTnT) and SensAheart testing was performed upon hospital admission. Diagnostic accuracy was computed using SensAheart or hs-cTnT levels versus the final diagnosis defined as positive/negative. <b><i>Results:</i></b> Of 225 patients analyzed, a final diagnosis of ACS was established in 138 patients, 87 individuals diagnosed with nonischemic chest pain. In the overall population, as compared to hs-cTnT, the sensitivity of the initial SensAheart assay was significantly higher (80.4 vs. 63.8%, <i>p</i> = 0.002) whereas specificity was lower (78.6 vs. 95.4%, <i>p</i> = 0.036). The overall diagnostic accuracy of SensAheart assay was similar to the hs-cTnT (82.7% compared to 76.0%, <i>p</i> = 0.08). <b><i>Conclusions:</i></b> Upon first medical contact, the novel point-of-care rapid SensAheart assay shows a diagnostic performance similar to hs-cTnT. The combination of 2 cardiac biomarkers in the same kit allows for very early detection of myocardial damage. The SensAheart assay is a reliable and practical tool for ruling-in the diagnosis of ACS.


2019 ◽  
pp. jramc-2018-001132
Author(s):  
Pierre Perrier ◽  
J Leyral ◽  
O Thabouillot ◽  
D Papeix ◽  
G Comat ◽  
...  

IntroductionTo evaluate the usefulness of point-of-care ultrasound (POCUS) performed by young military medicine residents after short training in the diagnosis of medical emergencies.MethodsA prospective study was performed in the emergency department of a French army teaching hospital. Two young military medicine residents received ultrasound training focused on gall bladder, kidneys and lower limb veins. After clinical examination, they assigned a ‘clinicaldiagnostic probability’ (CP) on a visual analogue scale from 0 (definitely not diagnosis) to 10 (definitive diagnosis). The same student performed ultrasound examination and assigned an ‘ultrasounddiagnostic probability’ (UP) in the same way. The absolute difference between CP and UP was calculated. This result corresponded to the Ultrasound Diagnostic Index (UDI), which was positive if UP was closer to the final diagnosis than CP (POCUS improved the diagnostic accuracy), and negative conversely (POCUS decreased the diagnostic accuracy).ResultsForty-eight patients were included and 48 ultrasound examinations were performed. The present pathologies were found in 14 patients (29%). The mean UDI value was +3 (0–5). UDI was positive in 35 exams (73%), zero in 12 exams (25%) and negative in only one exam (2%).ConclusionPOCUS performed after clinical examination increases the diagnostic accuracy of young military medicine residents.


2021 ◽  
pp. 174749302110409
Author(s):  
Chuanhui Li ◽  
Chuanjie Wu ◽  
Longfei Wu ◽  
Wenbo Zhao ◽  
Jian Chen ◽  
...  

Rationale There are no randomized trials examining the best treatment for acute basilar artery occlusion in the 6–24-hour time window. Aims To assess the safety and efficacy of thrombectomy for stroke due to basilar artery occlusion in patients randomized within 6–24 h from symptom onset or time last seen well. Sample size For an estimated difference of 20% in proportions of the primary outcome between the two groups, 318 patients will be included for 5% significance and 90% power with a planned interim analysis after two-thirds of the sample size (212 patients) have achieved the 90 days follow-up. Methods and design A prospective, multi-center, randomized, controlled, open-label and blinded-endpoint trial. The randomization employs a 1:1 ratio of mechanical thrombectomy with the detachable Solitaire thrombectomy device and best medical therapy (BMT) vs. BMT alone. Study outcomes The primary outcome will be the proportion of patients achieving modified Rankin Scale (mRS) 0–3 at 90 days. Key secondary outcomes are: dramatic early favorable response, dichotomized mRS score (0–2 vs. 3–6 and 0–4 vs. 5–6) at 90 days, ordinal (shift) mRS analysis at 90 days, infarct volume at 24 h, vessel recanalization at 24 h in both treatment arms, and successful recanalization in the thrombectomy arm according to the modified thrombolysis in cerebral infarction (mTICI) classification defined as mTICI 2 b or 3. Safety variables are mortality at 90 days, symptomatic intracranial hemorrhage rates at 24 h, and procedure-related complications. Discussion Results from this trial will indicate whether mechanical thrombectomy is superior to medical management alone in achieving favorable outcomes in subjects with acute stroke caused by basilar artery occlusion presenting within 6–24 h from symptom onset. Trial registration: URL: http://www.clinicaltrials.gov . ClinicalTrials.gov Identifier: NCT02737189.


2021 ◽  
Author(s):  
Weilian Geng ◽  
Changxing Chen ◽  
Xingfeng Sun ◽  
Shaoqiang Huang

Abstract Background The results of studies on changes in intracranial pressure in patients undergoing laparoscopic surgery are inconsistent. Meanwhile, previous neurosurgery studies have suggested that propofol and sevoflurane have inconsistent effects on cerebral blood flow and cerebrovascular self-regulation. The purpose of this study is to compare changes in the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery under anesthetic maintenance with propofol versus sevoflurane. Methods This study included 110 patients undergoing laparoscopic gynecological surgery with an estimated operative time of more than 2 hours under general anesthesia. The study was a randomized controlled study. The optic nerve sheath diameter(ONSD)at various time points was measured by ultrasound, including when the patients entered the operating room (Tawake), after successful anesthesia induction and endotracheal intubation (Tinduction), when the body position was adjusted to the Trendelenburg position and the CO2 pneumoperitoneum pressure reached 14 mmHg, which was recorded as T0. Then, measurements were conducted every 15 minutes for the first 1 hour and then once every hour until the end of the surgery(T15,T30,T45 ,T1h ,T2h…), after the end of surgery and the tracheal tube was removed (Tend), and before the patients were transferred to the ward (Tpacu).Results A significant difference in optic nerve sheath diameter was found between two groups at T15, T30, T45 (4.64±0.48mm and 4.50±0.29mm, respectively, p=0.031;4.77±0.45mm and 4.62±0.28mm, respectively, p=0.036;4.84±0.46mm and 4.65±0.30mm, respectively, p=0.012), while there was no significant difference at Tawake and other time points. Conclusion During laparoscopic gynecological surgery lasting more than 2 hours, the optic nerve sheath diameter was slightly larger in the propofol group than that in the sevoflurane group in the first 45 minutes. No significant difference was observed between the two groups 1 hour after surgery. Trial registration clinicaltrials.gov,NCT03498235. Retrospectively registered 1 March2018,https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0007UMM&selectaction=Edit&uid=U00040C5&ts=39&cx=c7i8icThe manuscript adheres to CONSORT guidelines.


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