Paul R Atkinson1, James Milne2, Laura Diegelmann3, Hein Lamprecht4, Melanie Stander4, David Lussier5, Chau Pham5, Ryan Henneberry6, Jacqueline M Fraser7, Michael K Howlett8, Jayanand Mekwan8, Brian Ramrattan8, Joanna Middleton8, Daniel J van Hoving4, Mandy Peach7, Luke Taylor7, Tara Dahn6, Sean Hurley6, Kayla MacSween6, Luke R Richardson6, George Stoica9, Samuel Hunter10, Paul A Olszynski11, David A Lewis8. 1. Department of Emergency Medicine, Dalhousie University, Saint John Regional Hospital, Saint John, New Brunswick, Canada; Dalhousie Medicine New Brunswick, Saint John, New Brunswick, Canada; Discipline of Emergency Medicine, Memorial University, Newfoundland and Labrador, Canada. Electronic address: paul.atkinson@dal.ca. 2. Fraser Health Authority, Vancouver, British Columbia, Canada. 3. Division of Emergency Medicine, University of Stellenbosch, Cape Town, South Africa; Department of Emergency Medicine, University of Maryland Medical Center, Baltimore, MD. 4. Division of Emergency Medicine, University of Stellenbosch, Cape Town, South Africa. 5. Department of Emergency Medicine, University of Manitoba, Health Sciences Centre, Winnipeg, Manitoba, Canada. 6. Department of Emergency Medicine, Dalhousie University, QEII, Halifax, Nova Scotia, Canada. 7. Department of Emergency Medicine, Dalhousie University, Saint John Regional Hospital, Saint John, New Brunswick, Canada. 8. Department of Emergency Medicine, Dalhousie University, Saint John Regional Hospital, Saint John, New Brunswick, Canada; Dalhousie Medicine New Brunswick, Saint John, New Brunswick, Canada; Discipline of Emergency Medicine, Memorial University, Newfoundland and Labrador, Canada. 9. Research Services, Horizon Health Network, Saint John Regional Hospital, Saint John, New Brunswick, Canada. 10. Faculty of Science, University of Ottawa, Ottawa, Ontario, Canada. 11. Department of Emergency Medicine, University of Saskatchewan, Royal University Hospital, Saskatoon, Saskatchewan, Canada.
Abstract
STUDY OBJECTIVE: Point-of-care ultrasonography protocols are commonly used in the initial management of patients with undifferentiated hypotension in the emergency department (ED). There is little published evidence for any mortality benefit. We compare the effect of a point-of-care ultrasonography protocol versus standard care without point-of-care ultrasonography for survival and clinical outcomes. METHODS: This international, multicenter, randomized controlled trial recruited from 6 centers in North America and South Africa and included selected hypotensive patients (systolic blood pressure <100 mm Hg or shock index >1) randomized to early point-of-care ultrasonography plus standard care versus standard care without point-of-care ultrasonography. Diagnoses were recorded at 0 and 60 minutes. The primary outcome measure was survival to 30 days or hospital discharge. Secondary outcome measures included initial treatment and investigations, admissions, and length of stay. RESULTS: Follow-up was completed for 270 of 273 patients. The most common diagnosis in more than half the patients was occult sepsis. We found no important differences between groups for the primary outcome of survival (point-of-care ultrasonography group 104 of 136 patients versus standard care 102 of 134 patients; difference 0.35%; 95% binomial confidence interval [CI] -10.2% to 11.0%), survival in North America (point-of-care ultrasonography group 76 of 89 patients versus standard care 72 of 88 patients; difference 3.6%; CI -8.1% to 15.3%), and survival in South Africa (point-of-care ultrasonography group 28 of 47 patients versus standard care 30 of 46 patients; difference 5.6%; CI -15.2% to 26.0%). There were no important differences in rates of computed tomography (CT) scanning, inotrope or intravenous fluid use, and ICU or total length of stay. CONCLUSION: To our knowledge, this is the first randomized controlled trial to compare point-of-care ultrasonography to standard care without point-of-care ultrasonography in undifferentiated hypotensive ED patients. We did not find any benefits for survival, length of stay, rates of CT scanning, inotrope use, or fluid administration. The addition of a point-of-care ultrasonography protocol to standard care may not translate into a survival benefit in this group.
RCT Entities:
STUDY OBJECTIVE: Point-of-care ultrasonography protocols are commonly used in the initial management of patients with undifferentiated hypotension in the emergency department (ED). There is little published evidence for any mortality benefit. We compare the effect of a point-of-care ultrasonography protocol versus standard care without point-of-care ultrasonography for survival and clinical outcomes. METHODS: This international, multicenter, randomized controlled trial recruited from 6 centers in North America and South Africa and included selected hypotensivepatients (systolic blood pressure <100 mm Hg or shock index >1) randomized to early point-of-care ultrasonography plus standard care versus standard care without point-of-care ultrasonography. Diagnoses were recorded at 0 and 60 minutes. The primary outcome measure was survival to 30 days or hospital discharge. Secondary outcome measures included initial treatment and investigations, admissions, and length of stay. RESULTS: Follow-up was completed for 270 of 273 patients. The most common diagnosis in more than half the patients was occult sepsis. We found no important differences between groups for the primary outcome of survival (point-of-care ultrasonography group 104 of 136 patients versus standard care 102 of 134 patients; difference 0.35%; 95% binomial confidence interval [CI] -10.2% to 11.0%), survival in North America (point-of-care ultrasonography group 76 of 89 patients versus standard care 72 of 88 patients; difference 3.6%; CI -8.1% to 15.3%), and survival in South Africa (point-of-care ultrasonography group 28 of 47 patients versus standard care 30 of 46 patients; difference 5.6%; CI -15.2% to 26.0%). There were no important differences in rates of computed tomography (CT) scanning, inotrope or intravenous fluid use, and ICU or total length of stay. CONCLUSION: To our knowledge, this is the first randomized controlled trial to compare point-of-care ultrasonography to standard care without point-of-care ultrasonography in undifferentiated hypotensive EDpatients. We did not find any benefits for survival, length of stay, rates of CT scanning, inotrope use, or fluid administration. The addition of a point-of-care ultrasonography protocol to standard care may not translate into a survival benefit in this group.
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