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Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport

This study has been terminated.
(Lack of technical support and supplies)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00279591
First received: January 17, 2006
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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, noninvasive blood pressure.


Condition Intervention
Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device
Device: Standard of care blood pressure monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care [ Time Frame: Up to two weeks ] [ Designated as safety issue: No ]
    This is the total number of participants analyzed for the intervention group and the total number of participants analyzed for the control group and the total number of days that each group was analyzed overall.


Secondary Outcome Measures:
  • Intensive Care Unit (ICU) Length of Stay [ Time Frame: Up to two weeks ] [ Designated as safety issue: No ]
  • Total Number of Organ Failure Days (Multiple Organ Dysfunction) in the Intensive Care Unit (ICU)for the Control Group and Total Number of Organ Failure Days for the Intervention Group. Multiple Organ Dysfunction is Defined as Multiple Organ Failure. [ Time Frame: Up to two weeks ] [ Designated as safety issue: No ]
    Total number of organ failure days is for each group as a whole.

  • Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale. [ Time Frame: Up to two weeks ] [ Designated as safety issue: No ]
    The Therapeutic Intervention Scoring System (TISS-28) is an illness severity score for the ICU. The TISS score can range from zero up to 78. The higher the score is, the more severe the illness. The TISS-28 scale measures the severity of a patient's illness.

  • Amount of Intravenous Fluid Resuscitation [ Time Frame: At start of inter-facility transport, then every 15 minutes until arrival. ] [ Designated as safety issue: No ]

Enrollment: 94
Study Start Date: June 2006
Study Completion Date: January 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuous Blood Pressure Monitoring
Patients received continuous blood pressure monitoring the entire time they were in med flight to the hospital.
Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device
Continuous blood pressure monitoring of patients during med flight to hospital
Placebo Comparator: Standard of care blood pressure monitoring
Patients received the normal standard of care for blood pressure monitoring during the course of the med flight to the hospital.
Device: Standard of care blood pressure monitoring
Patients received the standard of care for blood pressure monitoring while en route to the hospital via med flight.

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 blood pressure device (Vasotrac).

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00279591     History of Changes
Other Study ID Numbers: 48082, CUMG Grant
Study First Received: January 17, 2006
Results First Received: March 28, 2011
Last Updated: April 3, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on November 25, 2014