Back to resultsNear-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
Primary Purpose
Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device
Standard of care blood pressure monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
Eligibility Criteria
Inclusion Criteria: 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. OR 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: 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.
Sites / Locations
- Arkansas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Continuous Blood Pressure Monitoring
Standard of care blood pressure monitoring
Arm Description
Patients received continuous blood pressure monitoring the entire time they were in med flight to the hospital.
Patients received the normal standard of care for blood pressure monitoring during the course of the med flight to the hospital.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Intensive Care Unit (ICU) Length of Stay
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.
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.
Amount of Intravenous Fluid Resuscitation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00279591
Brief Title
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
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of technical support and supplies
Study Start Date
June 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous Blood Pressure Monitoring
Arm Type
Active Comparator
Arm Description
Patients received continuous blood pressure monitoring the entire time they were in med flight to the hospital.
Arm Title
Standard of care blood pressure monitoring
Arm Type
Placebo Comparator
Arm Description
Patients received the normal standard of care for blood pressure monitoring during the course of the med flight to the hospital.
Intervention Type
Device
Intervention Name(s)
Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device
Intervention Description
Continuous blood pressure monitoring of patients during med flight to hospital
Intervention Type
Device
Intervention Name(s)
Standard of care blood pressure monitoring
Intervention Description
Patients received the standard of care for blood pressure monitoring while en route to the hospital via med flight.
Primary Outcome Measure Information:
Title
The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care
Description
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.
Time Frame
Up to two weeks
Secondary Outcome Measure Information:
Title
Intensive Care Unit (ICU) Length of Stay
Time Frame
Up to two weeks
Title
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.
Description
Total number of organ failure days is for each group as a whole.
Time Frame
Up to two weeks
Title
Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.
Description
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.
Time Frame
Up to two weeks
Title
Amount of Intravenous Fluid Resuscitation
Time Frame
At start of inter-facility transport, then every 15 minutes until arrival.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
OR
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stroud, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21173006
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.
Results Reference
result
Learn more about this trial
Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
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