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.

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 Continuous noninvasive hemoglobin monitoring estimates timing for detecting anemia better than clinicians: A randomized controlled trial

2019 ◽  
Author(s):  
Bo Tang ◽  
Xuerong Yu ◽  
Li Xu ◽  
Afang Zhu ◽  
Yuelun Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Care Group ◽  
Exact Test ◽  
Randomized Controlled ◽  
Care Groups ◽  
Transfusion Volume ◽  
Better Than

Abstract Background Hemoglobin measurement is important for transfusion decision-making. Pulse CO-Oximetry provides real-time continuous hemoglobin (SpHb) monitoring. The triage role of SpHb trends based on hemoglobin measurements was investigated. Methods In this diagnostic randomized controlled trial, 69 patients undergoing spine or cytoreductive surgery were randomly enrolled into SpHb-monitoring and standard-care groups. Diagnostic blood samples were drawn for CO-oximetry Hb (CoOxHb) when the SpHb decreased by 1 g/dl or at the clinician’s discretion in the standard-care group. The positive predictive value (PPV) was defined as the ability to detect a decrease in CoOxHb > 1 g/dl or a CoOxHb < 10 g/dl; the PPVs were compared using Fisher’s exact test. The SpHb and trend accuracies were calculated. The transfusion units and postoperative hemoglobin levels were compared. Results The PPV of a decrease in CoOxHb > 1 g/dl was 93.3% in the SpHb group vs 54.5% without SpHb monitoring (p = 0.002). The PPV of CoOxHb < 10 g/dl was 86.7% vs. 50.0% for these groups (p = 0.015). The CoOxHb was never < 7 g/dl with SpHb monitoring. Sixty SpHb–CoOxHb data pairs and 28 delta pairs (ΔSpHb-ΔCoOxHb) were collected. The bias, precision and limits of agreement were -0.29, 1.03 and -2.30 to 1.72 g/dl, respectively. When ΔSpHb and ΔCoOxHb were > 1 g/dl, the concordance rate for changes in hemoglobin reached 100%. The delta pairs revealed a positive correlation [ΔSpHb = 0.49 * ΔCoOxHb - 0.13; r = 0.69, 95% confidence interval (0.53, 0.82)]. No significant differences were found in the transfusion volume or postoperative anemia state. Conclusions The SpHb trend tracked changes in hemoglobin satisfactorily during surgery and more accurately estimated the appropriate timing for invasive hemoglobin measurements than the clinicians. Trial Registration ChiCTR1800016290, Date of registration 24 May 2018.

scholarly journals Continuous noninvasive hemoglobin monitoring estimates timing for detecting anemia better than clinicians: A randomized controlled trial

2019 ◽  
Author(s):  
Bo Tang ◽  
Xuerong Yu ◽  
Li Xu ◽  
Afang Zhu ◽  
Yuelun Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Care Group ◽  
Exact Test ◽  
Randomized Controlled ◽  
Care Groups ◽  
Transfusion Volume ◽  
Better Than

Abstract Background Hemoglobin measurement is important for transfusion decision-making. Pulse CO-Oximetry provides real-time continuous hemoglobin (SpHb) monitoring. The triage role of SpHb trends based on hemoglobin measurements was investigated. Methods In this diagnostic randomized controlled trial, 69 patients undergoing spine or cytoreductive surgery were randomly enrolled into SpHb-monitoring and standard-care groups. Diagnostic blood samples were drawn for CO-oximetry Hb (CoOxHb) when the SpHb decreased by 1 g/dl or at the clinician’s discretion in the standard-care group. The positive predictive value (PPV) was defined as the ability to detect a decrease in CoOxHb > 1 g/dl or a CoOxHb < 10 g/dl; the PPVs were compared using Fisher’s exact test. The SpHb and trend accuracies were calculated. The transfusion units and postoperative hemoglobin levels were compared. Results The PPV of a decrease in CoOxHb > 1 g/dl was 93.3% in the SpHb group vs 54.5% without SpHb monitoring (p = 0.002). The PPV of CoOxHb < 10 g/dl was 86.7% vs. 50.0% for these groups (p = 0.015). The CoOxHb was never < 7 g/dl with SpHb monitoring. Sixty SpHb–CoOxHb data pairs and 28 delta pairs (ΔSpHb-ΔCoOxHb) were collected. The bias, precision and limits of agreement were -0.29, 1.03 and -2.30 to 1.72 g/dl, respectively. When ΔSpHb and ΔCoOxHb were > 1 g/dl, the concordance rate for changes in hemoglobin reached 100%. The delta pairs revealed a positive correlation [ΔSpHb = 0.49 * ΔCoOxHb - 0.13; r = 0.69, 95% confidence interval (0.53, 0.82)]. No significant differences were found in the transfusion volume or postoperative anemia state. Conclusions The SpHb trend tracked changes in hemoglobin satisfactorily during surgery and more accurately estimated the appropriate timing for invasive hemoglobin measurements than the clinicians. Trial Registration ChiCTR1800016290, Date of registration

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&lt;100 or shock index&gt;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 Continuous noninvasive hemoglobin monitoring estimates timing for detecting anemia better than clinicians: A randomized controlled trial

2019 ◽  
Author(s):  
Bo Tang ◽  
Xuerong Yu ◽  
Li Xu ◽  
Afang Zhu ◽  
Yuelun Zhang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Care Group ◽  
Exact Test ◽  
Randomized Controlled ◽  
Care Groups ◽  
Transfusion Volume ◽  
Registration Date

Abstract Background Hemoglobin measurement is important for transfusion decision-making. Pulse CO-Oximetry provides real-time continuous hemoglobin (SpHb) monitoring. The triage role of SpHb trends based on hemoglobin measurements was investigated. Methods In this diagnostic randomized controlled trial, 69 patients undergoing spine or cytoreductive surgery were randomly enrolled into SpHb-monitoring and standard-care groups. Diagnostic blood samples were drawn for CO-oximetry Hb (CoOxHb) when the SpHb decreased by 1 g/dl or at the clinician’s discretion in the standard-care group. The positive predictive value (PPV) was defined as the ability to detect a decrease in CoOxHb > 1 g/dl or a CoOxHb < 10 g/dl; the PPVs were compared using Fisher’s exact test. The SpHb and trend accuracies were calculated. The transfusion units and postoperative hemoglobin levels were compared. Results The PPV of a decrease in CoOxHb > 1 g/dl was 93.3% in the SpHb group vs 54.5% without SpHb monitoring (p = 0.002). The PPV of CoOxHb < 10 g/dl was 86.7% vs. 50.0% for these groups (p = 0.015). The CoOxHb was never < 7 g/dl with SpHb monitoring. Sixty SpHb–CoOxHb data pairs and 28 delta pairs (ΔSpHb-ΔCoOxHb) were collected. The bias, precision and limits of agreement were -0.29, 1.03 and -2.30 to 1.72 g/dl, respectively. When ΔSpHb and ΔCoOxHb were > 1 g/dl, the concordance rate for changes in hemoglobin reached 100%. The delta pairs revealed a positive correlation [ΔSpHb = 0.49 * ΔCoOxHb - 0.13; r = 0.69, 95% confidence interval (0.53, 0.82)]. No significant differences were found in the transfusion volume or postoperative anemia state. Conclusions The SpHb trend tracked changes in hemoglobin satisfactorily during surgery and more accurately estimated the appropriate timing for invasive hemoglobin measurements than the clinicians. Trial Registration ChiCTR1800016290 (Prospective registered). Initial registration date was 24/05/2018.

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