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Sponsored by: |
University of Arkansas |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00279591 |
A randomized controlled trial design will compare the clinical outcomes of transported pediatric patients monitored with an oscillometric blood pressure device versus those monitored with a near-continuous, noninvasive blood pressure.
Hypothesis: Near-continuous, noninvasive blood pressure monitoring for pre-hospital hypotension during transport of critically ill pediatric patients will improve their clinical outcome by reducing their hospital length of stay by 25%.
Condition | Intervention |
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Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome) |
Device: (Dinamap) standard oscillometric blood pressure device versus noninvasive blood pressure device (vasotrac) |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport |
Estimated Enrollment: | 115 |
Study Start Date: | January 2006 |
We plan to randomize 115 transported patients to a control arm, monitored with a standard oscillometric blood pressure device (Dinamap), and 115 patients to an experimental arm, monitored with a near-continuous, noninvasive blood pressure device (Vasotrac). This will allow us to detect a 25% reduction in hospital length of stay with >90% power and a two tailed alpha of 0.01.
Ages Eligible for Study: | 1 Year to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients at risk of developing SIRS (Systemic Inflammatory Response Syndrome), according to the criteria below.
i. The presence of at least two of the following four criteria (one of which must be abnormal temperature or leukocyte count): A. Core temperature of >38.5 C or <36 C. B. Tachycardia, defined as mean heart rate >95th percentile for age in absence of external stimulus, chronic drugs, or painful stimuli.
C. Mean respiratory rate >95th percentile for age, or >10% immature neutrophils.
OR
Patients with moderate or severe head trauma, at risk of developing secondary ischemic brain injury, according to the criteria below.
i. Glasgow Coma scale <15 with one or more of the following: A. Mass lesion or cerebral edema on CT or MRI scan. B. Post-Traumatic Seizure. C. Multiple Trauma. D. Focal Neurologic Signs. E. Intubation for control of suspected intracranial hypertension.
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Exclusion Criteria:
United States, Arkansas | |
Arkansas Children's Hospital | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Michael Stroud, MD | University of Arkansas |
Study ID Numbers: | 48082, CUMG Grant |
Study First Received: | January 17, 2006 |
Last Updated: | November 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00279591 |
Health Authority: | United States: Food and Drug Administration |
Systemic Inflammatory Response Syndrome Shock Inflammation |
Pathologic Processes |