Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00279591|
Recruitment Status : Terminated (Lack of technical support and supplies)
First Posted : January 19, 2006
Results First Posted : April 30, 2012
Last Update Posted : April 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)||Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device Device: Standard of care blood pressure monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Near-Continuous, Noninvasive Blood Pressure Monitoring to Improve Outcomes in Pediatric Transport|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||January 2008|
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.
- The Difference in Hospital Length of Stay Between Those Who Received Continuous Blood Pressure Monitoring and Those Who Received Standard of Care [ Time Frame: Up to two weeks ]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.
- Intensive Care Unit (ICU) Length of Stay [ Time Frame: 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. [ Time Frame: Up to two weeks ]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. [ Time Frame: Up to two weeks ]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 [ Time Frame: At start of inter-facility transport, then every 15 minutes until arrival. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279591
|United States, Arkansas|
|Arkansas Children's Hospital|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Michael Stroud, MD||University of Arkansas|