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

NCT ID: NCT00279591

Last Updated: 2012-04-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-01-31

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).

Conditions

Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Continuous Blood Pressure Monitoring

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Continuous blood pressure monitoring of patients during med flight to hospital

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.

Group Type: PLACEBO_COMPARATOR

Standard of care blood pressure monitoring

Intervention Type: DEVICE

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

Interventions

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

Continuous blood pressure monitoring of patients during med flight to hospital

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Stroud, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21173006 (View on PubMed)

Other Identifiers

CUMG Grant

Identifier Type: -

Identifier Source: secondary_id

48082

Identifier Type: -

Identifier Source: org_study_id