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Emergency Bedside Ultrasound for Pediatric Soft Tissue Infections

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ClinicalTrials.gov Identifier: NCT00595881
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : December 27, 2012
Last Update Posted : December 31, 2012
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Condition: Abscess
Intervention: Device: Bedside emergency ultrasound

  Participant Flow

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

Participant Flow:   Overall Study
STARTED   420 

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   420 
Between 18 and 65 years   0 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 7.8  (6) 
[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 ]

  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

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

Single institution

  More Information

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00595881     History of Changes
Other Study ID Numbers: 2007-6-5388
First Submitted: January 7, 2008
First Posted: January 16, 2008
Results First Submitted: July 13, 2011
Results First Posted: December 27, 2012
Last Update Posted: December 31, 2012