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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

January 17, 2006
April 3, 2012
June 2006
June 2007   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00279591 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
  • Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device
    Continuous blood pressure monitoring of patients during med flight to 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.
  • Active Comparator: Continuous Blood Pressure Monitoring
    Patients received continuous blood pressure monitoring the entire time they were in med flight to the hospital.
    Intervention: Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device
  • 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.
    Intervention: Device: Standard of care blood pressure monitoring
Stroud MH, Prodhan P, Moss M, Fiser R, Schexnayder S, Anand K. Enhanced monitoring improves pediatric transport outcomes: a randomized controlled trial. Pediatrics. 2011 Jan;127(1):42-8. doi: 10.1542/peds.2010-1336. Epub 2010 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
94
January 2008
June 2007   (final data collection date for primary outcome measure)

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.
Both
1 Year to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00279591
48082, CUMG Grant
No
University of Arkansas
University of Arkansas
Not Provided
Principal Investigator: Michael Stroud, MD University of Arkansas
University of Arkansas
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP