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

NCT00279591 | Terminated Results

• 2 other identifiers: 48082CUMG Grant
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

  Up to two weeks

• Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.

  Up to two weeks

• Amount of Intravenous Fluid Resuscitation

  At start of inter-facility transport, then every 15 minutes until arrival.

Study Arms (2)

Continuous Blood Pressure Monitoring

ACTIVE COMPARATOR

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

Standard of care blood pressure monitoring

PLACEBO COMPARATOR

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

Interventions

Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device DEVICE

Continuous blood pressure monitoring of patients during med flight to hospital

Continuous Blood Pressure Monitoring

Standard of care blood pressure monitoring DEVICE

Patients received the standard of care for blood pressure monitoring while en route to the hospital via med flight.

Standard of care blood pressure monitoring

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• 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.

  PMID: 21173006 RESULT

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Limitations and Caveats

Small Sample Size. Halted prior to projected enrollment secondary to lack of technical support and supplies for near continuous BP measuring device.

Results Point of Contact

• Title: Dr. Michael Stroud
• Organization: University of Arkansas for Medical Sciences

StroudMichaelH@uams.edu

501-364-1861

Study Officials

• Michael Stroud, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2006
• First Posted: January 19, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: January 1, 2008
• Last Updated: April 30, 2012
• Results First Posted: April 30, 2012

Record last verified: 2012-04

Locations

US (1)