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

NCT02507674 | Completed

• 1 other identifier: Pro00062947
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

Appendicitis

Keywords

appendicitis; pediatric; ultrasound

Outcome Measures

Primary Outcomes (1)

• Experimental ultrasound diagnosis agreement with final reference standard diagnosis

  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.

  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.

Secondary Outcomes (3)

• Duration of experimental ultrasound exam (seconds)

  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)

  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.

  4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks.

Interventions

ultrasound DEVICE

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects must be 0-18 years of age, presenting to the pediatric emergency department for evaluation of right lower abdominal pain and suspected appendicitis. The clinical diagnostic plan before subject enrollment must include abdominal ultrasound and/or abdominal CT.

You may qualify if:

• Potential subjects must be 0-18 years of age, presenting to the pediatric emergency department for evaluation of right lower abdominal pain and suspected appendicitis.
• The clinical diagnostic plan before subject enrollment must include abdominal ultrasound and/or abdominal CT.

You may not qualify if:

• Because ultrasound does not involve the use of ionizing radiation or contrast agents, it is not contraindicated in any patients, although image quality may be nondiagnostic in obese patients. The focus of this study is on acquisition of research 3D POC US images to determine feasibility of use in pediatric patients with suspected appendicitis.
• Patients with BMI \>30 or mass \>70kg, as these patients are anticipated to have nondiagnostic ultrasound images.

Sponsors & Collaborators

• Duke University: lead
• Wallace H. Coulter Foundation: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 24, 2015
• Study Start: October 1, 2015
• Primary Completion: June 16, 2016
• Study Completion: July 16, 2016
• Last Updated: January 30, 2020

Record last verified: 2020-01

Locations

US (1)