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. 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
Information provided by (Responsible Party):
University of Arkansas

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (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

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
No text entered.

Reporting Groups
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 48   46   94 
[Units: Participants]
<=18 years   48   46   94 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 8.5  (5.6)   6.5  (4.6)   7.5  (5.1) 
[Units: Participants]
Female   20   16   36 
Male   28   30   58 
Region of Enrollment 
[Units: Participants]
United States   48   46   94 

  Outcome Measures

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

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

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

Publications of Results:

Responsible Party: University of Arkansas Identifier: NCT00279591     History of Changes
Other Study ID Numbers: 48082
CUMG Grant
First Submitted: January 17, 2006
First Posted: January 19, 2006
Results First Submitted: March 28, 2011
Results First Posted: April 30, 2012
Last Update Posted: April 30, 2012