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

This study has been terminated.
(Lack of technical support and supplies)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00279591
First received: January 17, 2006
Last updated: April 3, 2012
Last verified: April 2012
Results First Received: March 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)
Interventions: Device: Continuous blood pressure monitoring using (Dinamap) standard oscillometric blood pressure device
Device: Standard of care blood pressure monitoring

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pediatric interfacility helicopter transport patients between May 2006 and June 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control Group Oscillometric Blood Pressure Monitoring
Intervention Group Near Continuous Blood Pressure Monitoring

Participant Flow:   Overall Study
    Control Group     Intervention Group  
STARTED     48     46  
COMPLETED     48     46  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group Oscillometric Blood Pressure Monitoring
Intervention Group Near Continuous Blood Pressure Monitoring
Total Total of all reporting groups

Baseline Measures
    Control Group     Intervention Group     Total  
Number of Participants  
[units: participants]
  48     46     94  
Age  
[units: participants]
     
<=18 years     48     46     94  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  8.5  ± 5.6     6.5  ± 4.6     7.5  ± 5.1  
Gender  
[units: participants]
     
Female     20     16     36  
Male     28     30     58  
Region of Enrollment  
[units: participants]
     
United States     48     46     94  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Intensive Care Unit (ICU) Length of Stay   [ Time Frame: Up to two weeks ]

3.  Secondary:   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 ]

4.  Secondary:   Mean Daily Score Using the Therapeutic Intervention Scoring System (TISS-28) Scale.   [ Time Frame: Up to two weeks ]

5.  Secondary:   Amount of Intravenous Fluid Resuscitation   [ Time Frame: At start of inter-facility transport, then every 15 minutes until arrival. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small Sample Size. Halted prior to projected enrollment secondary to lack of technical support and supplies for near continuous BP measuring device.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael Stroud
Organization: University of Arkansas for Medical Sciences
phone: 501-364-1861
e-mail: StroudMichaelH@uams.edu


Publications of Results:

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00279591     History of Changes
Other Study ID Numbers: 48082, CUMG Grant
Study First Received: January 17, 2006
Results First Received: March 28, 2011
Last Updated: April 3, 2012
Health Authority: United States: Food and Drug Administration