Clinical trial NCT00279591: Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
Official title: Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2006-01-19
Enrollment: 94
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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.

Primary outcomes:
measure: The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care
timeFrame: Up to two weeks
Secondary outcomes:
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: Up to two weeks
measure: 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.
timeFrame: Up to two weeks
measure: Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.
timeFrame: Up to two weeks
measure: Amount of Intravenous Fluid Resuscitation
timeFrame: At start of inter-facility transport, then every 15 minutes until arrival.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Michael Stroud, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.