Status:
TERMINATED
Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
Lead Sponsor:
University of Arkansas
Conditions:
Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
Eligibility:
All Genders
1-17 years
Phase:
NA
Brief Summary
A randomized controlled trial compared the clinical outcomes of transported pediatric patients monitored with an oscillometric blood pressure device versus those monitored with a near-continuous, noni...
Detailed Description
94 transported patients were randomized to a control arm, monitored with a standard oscillometric blood pressure device (Dinamap), or an experimental arm, monitored with a near-continuous, noninvasive...
Eligibility Criteria
Inclusion
- Pediatric patients transported by Angel One to Arkansas Children's Hospital.
- Age Group: 1 year - 17 years AND
- 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.
- \-
Exclusion
- Wrist circumference less than 11cm (minimum size for the Vasotrac device).
- Contractures of the wrists, not allowing correct placement of the Vasotrac device.
- Hematoma(s) located on both wrists from recent redial (\<24hr) artery puncture.
- Patients likely to proceed to brain death per assessment of the referring physician.
- Patients being treated for malignant hypertension.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00279591
Start Date
June 1 2006
End Date
January 1 2008
Last Update
April 30 2012
Active Locations (1)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72205