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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)

Intervention / Treatment
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* Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device
* Device: Standard of care blood pressure monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Blood Pressure Monitoring<br>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<br>* Continuous blood pressure monitoring of patients during med flight to hospital<br>|
| Placebo Comparator: Standard of care blood pressure monitoring<br>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<br>* Patients received the standard of care for blood pressure monitoring while en route to the hospital via med flight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care | 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. | Up to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit (ICU) Length of Stay |  | Up to two weeks | 
| 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. | Total number of organ failure days is for each group as a whole. | Up to two weeks | 
| Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale. | 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. | Up to two weeks | 
| Amount of Intravenous Fluid Resuscitation |  | At start of inter-facility transport, then every 15 minutes until arrival. |