Clinical Trial: Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study

Brief Summary:

  1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound for pediatric appendicitis. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen.
  2. Study activities and population group. The study population will be a convenience sample of patients 18 years and younger with suspected appendicitis, whose clinical care (unrelated to the study) includes ultrasound and/or CT of the abdomen. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. If not evident from the patient medical record, the final diagnosis will be confirmed by a telephone call to the subject 2 weeks after the initial visit.
  3. Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images to determine the frequency of visualization of the appendix and whether the appendix was deemed normal or abnormal. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality.

This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not

Detailed Summary:
Sponsor: Duke University

Current Primary Outcome: Experimental ultrasound diagnosis agreement with final reference standard diagnosis [ Time Frame: Comparison of experimental ultrasound diagnosis with final reference diagnosis will occur at approximately 4 weeks (average) after date of experimental ultrasound exam, to allow clinical follow-up to occur. ]

Agreement will be measured as simple agreement and with adjusted agreement (Cohen's kappa). Sensitivity and specificity will also be calculated by comparing the experimental ultrasound result with the final reference diagnosis.


Original Primary Outcome: Experimental ultrasound diagnosis agreement with final reference standard diagnosis [ Time Frame: Comparison of experimental ultrasound diagnosis with final reference diagnosis will occur at approximately 4 weeks (average) after date of experimental ultrasound exam, to allow clinical follow-up to occur. ]

Current Secondary Outcome:

  • Duration of experimental ultrasound exam (seconds) [ Time Frame: The duration of the experimental ultrasound exam in seconds will be digitally recorded at the time of its performance. We anticipate the ultrasound duration to be less than 600 seconds. ]
  • Appendix visualized by experimental ultrasound (yes/no) [ Time Frame: 4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks. ]
  • Experimental ultrasound image quality. [ Time Frame: 4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks. ]
    Visual analogue scale/Likert scale


Original Secondary Outcome:

  • Duration of experimental ultrasound exam (seconds) [ Time Frame: The duration of the experimental ultrasound exam in seconds will be digitally recorded at the time of its performance. We anticipate the ultrasound duration to be less than 10 minutes. ]
  • Appendix visualized by experimental ultrasound (yes/no) [ Time Frame: 4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks. ]
  • Experimental ultrasound image quality. [ Time Frame: 4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks. ]
    Visual analogue scale/Likert scale


Information By: Duke University

Dates:
Date Received: July 22, 2015
Date Started: October 2015
Date Completion: January 2018
Last Updated: March 21, 2017
Last Verified: March 2017