scholarly journals LO44: Initial validation of the core components in the SHoC-Hypotension Protocol. What rates of ultrasound findings are reported in emergency department patients with undifferentiated hypotension? Results from 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. S42-S43
Author(s):  
D. Lussier ◽  
C. Pham ◽  
J. Milne ◽  
D. Lewis ◽  
L. Diegelmann ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Peritoneal Fluid ◽  
Standard Care ◽  
Controlled Trial ◽  
Lv Function ◽  
Point Of Care Ultrasound ◽  
The Core ◽  
Randomized Controlled ◽  
Ultrasound Findings

Introduction: Point of care ultrasound (PoCUS) has become an established tool in the initial management of patients with undifferentiated hypotension in the emergency department (ED). Current established protocols (e.g. RUSH and ACES) were developed by expert user opinion, rather than objective, prospective data. Recently the SHoC Protocol was published, recommending 3 core scans; cardiac, lung, and IVC; plus other scans when indicated clinically. We report the abnormal ultrasound findings from our international multicenter randomized controlled trial, to assess if the recommended 3 core SHoC protocol scans were chosen appropriately for this population. Methods: Recruitment occurred at seven centres in North America (4) and South Africa (3). Screening at triage identified patients (SBP<100 or shock index>1) who were randomized to PoCUS or control (standard care with no PoCUS) groups. All scans were performed by PoCUS-trained physicians within one hour of arrival in the ED. Demographics, clinical details and study findings were collected prospectively. A threshold incidence for positive findings of 10% was established as significant for the purposes of assessing the appropriateness of the core recommendations. Results: 138 patients had a PoCUS screen completed. All patients had cardiac, lung, IVC, aorta, abdominal, and pelvic scans. Reported abnormal findings included hyperdynamic LV function (59; 43%); small collapsing IVC (46; 33%); pericardial effusion (24; 17%); pleural fluid (19; 14%); hypodynamic LV function (15; 11%); large poorly collapsing IVC (13; 9%); peritoneal fluid (13; 9%); and aortic aneurysm (5; 4%). Conclusion: The 3 core SHoC Protocol recommendations included appropriate scans to detect all pathologies recorded at a rate of greater than 10 percent. The 3 most frequent findings were cardiac and IVC abnormalities, followed by lung. It is noted that peritoneal fluid was seen at a rate of 9%. Aortic aneurysms were rare. This data from the first RCT to compare PoCUS to standard care for undifferentiated hypotensive ED patients, supports the use of the prioritized SHoC protocol, though a larger study is required to confirm these findings.

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 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 LO63: Humanoid robot-based distraction to reduce pain and distress during venipuncture in the pediatric emergency department: A randomized controlled trial

CJEM ◽  
2019 ◽  
Vol 21 (S1) ◽  
pp. S30-S31 ◽  
Author(s):  
S. Ali ◽  
R. Manaloor ◽  
K. Ma ◽  
M. Sivakumar ◽  
B. Vandermeer ◽  
...  
Keyword(s):  
Emergency Department ◽  
Randomized Controlled Trial ◽  
Standard Care ◽  
Humanoid Robot ◽  
Controlled Trial ◽  
Care Group ◽  
Robot Arm ◽  
Negative Consequences ◽  
Randomized Controlled ◽  
Robot Group

Introduction: Intravenous insertion (IVI) is identified by children as extremely painful and the resultant distress can have lasting negative consequences. There is an urgent need to effectively manage such procedures. Our primary objective was to compare the pain and distress of IVI with the addition of humanoid robot-based distraction to standard care, versus standard care alone. Methods: This two-armed randomized controlled trial (RCT) was conducted from April 2017 to May 2018 at the Stollery Children's Hospital emergency department (ED). Children aged 6 to 11 years who required IVI were included. Exclusion criteria included hearing or visual impairments, neurocognitive delays, sensory impairment to pain, previous enrolment, and discretion of the ED clinical staff. Primary outcomes were measured using the Observational Scale of Behavioural Distress-Revised (OSBD-R) (distress) and the Faces Pain Scale-Revised (FPS-R) (pain). A total of 426 pediatric patients were screened and 340 were excluded. Results: We recruited 86 children, of which 55% (47/86) were male; 9% (7/82) were premature at birth; 82% (67/82) had a previous ED visit; 30% (25/82) required previous hospitalization; 78% (64/82) had previous IV placement and 96% (78/81) received topical anesthesia. The mean total OSBD-R score was 1.49 ± 2.36 (standard care) compared to 0.78 ± 1.32 (robot group) (p = 0.047). The median FPS-R during the IV procedure was 4 (IQR 2,6) in the standard care group alone, compared to 2 (IQR 0,4) with the addition of humanoid robot-based distraction (p = 0.10). Change in parental state anxiety pre-procedure versus post-procedure was not significantly different between groups (p = 0.49). Parental satisfaction with the IV start was 93% (39/42) in the robot arm compared to 74% (29/39) in the standard care arm (p = 0.03). Parents were also more satisfied with management of their child's pain in the robot group (95% very satisfied) compared with standard care (72% very satisfied) (p = 0.002). Conclusion: A statistically significant reduction in distress was observed with the addition of robot-based distraction to standard care. Humanoid robot-based distraction therapy reduces distress and to a lesser extent, pain, in children undergoing IVI in the ED. Further trials are required to confirm utility in other age groups and settings.

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