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.

Study Overview

• Status: Terminated
• Conditions: Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
• Intervention / Treatment: Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device; Device: Standard of care blood pressure monitoring

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).

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Michael Stroud, MD, University of Arkansas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: January 17, 2006
• First Submitted That Met QC Criteria: January 17, 2006
• First Posted (Estimate): January 19, 2006

Study Record Updates

• Last Update Posted (Estimate): April 30, 2012
• Last Update Submitted That Met QC Criteria: April 3, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Shock; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: 48082; CUMG Grant

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No