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Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
This study is ongoing, but not recruiting participants.
Sponsored by: University of Arkansas
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00279591
  Purpose

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
Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
Device: (Dinamap) standard oscillometric blood pressure device versus noninvasive blood pressure device (vasotrac)

U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport

Further study details as provided by University of Arkansas:

Estimated Enrollment: 115
Study Start Date: January 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pediatric patients transported by Angel One to Arkansas Children's Hospital.
  2. Age Group: 1 year - 17 years AND
  3. 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

  4. 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 Criteria:

  1. Wrist circumference less than 11cm (minimum size for the Vasotrac device).
  2. Contractures of the wrists, not allowing correct placement of the Vasotrac device.
  3. Hematoma(s) located on both wrists from recent redial (<24hr) artery puncture.
  4. Patients likely to proceed to brain death per assessment of the referring physician.
  5. Patients being treated for malignant hypertension.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279591

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Michael Stroud, MD University of Arkansas
  More Information

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

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Shock
Inflammation

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009