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

University of Arkansas

Status: Terminated

Conditions: Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)

Treatments: Device: Standard of care blood pressure monitoring; Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device

Study type: Interventional

Funder types: Other

Identifiers

NCT00279591

48082

CUMG Grant

Details and patient eligibility

About

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.

Full 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).

Enrollment: 94 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

Continuous Blood Pressure Monitoring

Active Comparator group

Description:

Patients received continuous blood pressure monitoring the entire time they were in med flight to the hospital.

Treatment:

Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device

Standard of care blood pressure monitoring

Placebo Comparator group

Description:

Patients received the normal standard of care for blood pressure monitoring during the course of the med flight to the hospital.

Treatment:

Device: Standard of care blood pressure monitoring