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Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00595881
First received: January 7, 2008
Last updated: December 27, 2012
Last verified: February 2012
History of Changes
Results First Received: July 13, 2011  
Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Condition: Abscess
Intervention: Device: Bedside emergency ultrasound

  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
Patients were recruited over a 22 month period

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ultrasound One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.

Participant Flow:   Overall Study
    Ultrasound  
STARTED     420  
COMPLETED     420  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Ultrasound One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.

Baseline Measures
    Ultrasound  
Number of Participants  
[units: participants]
 		  420  
Age  
[units: participants]
 		 
<=18 years     420  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  7.8  ± 6  
Gender  
[units: participants]
 		 
Female     218  
Male     202  
Region of Enrollment  
[units: participants]
 		 
United States     420  



  Outcome Measures

1.  Primary:   Sensitivity and Specificity of Bedside Emergency Ultrasound When Added to the Clinical Examination Compared With Clinical Examination Alone.   [ Time Frame: 18 mos ]
  Show Outcome Measure 1


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


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

Potential misclassification of lesions based on reference standard. Biased lesion outcome, as ultrasound results were not incorporated into patient care.

Single institution

 


Results Point of Contact:  
Name/Title: Jennifer Marin
Organization: Children's Hospital of Pittsburgh
phone: 412-692-7692
e-mail: jennifer.marin@chp.edu


No publications provided


Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00595881     History of Changes
Other Study ID Numbers: 2007-6-5388
Study First Received: January 7, 2008
Results First Received: July 13, 2011
Last Updated: December 27, 2012
Health Authority: United States: Institutional Review Board