Point of Care Ultrasound for Evaluation of Suspected Appendicitis in the Emergency Department

NCT02731924 | Completed

• 1 other identifier: 549570-8
• Study Type: observational
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine the accuracy of ultrasound (US) in diagnosing appendicitis in emergency department (ED) patients, as compared to the criterion standards of computed tomography, operative reports, or discharge diagnosis. The secondary purposes of the study include evaluation of the effect of ultrasound for appendicitis on the patient length of stay in the emergency department, the diagnostic utility of specific ultrasound findings in the diagnosis of appendicitis, the role of body mass index (BMI) in the utility of ultrasound for appendicitis and relation of ultrasound findings to the Alvarado score. The study will also examine the inter-rater agreement between point-of- care sonographers' interpretation and blinded reviewers' interpretation of the ultrasound images.

Conditions

Acute Appendicitis

Keywords

Appendicitis; Ultrasound; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Point-of-care Ultrasound for Suspected Appendicitis

  The performance of point-of-care ultrasound for appendicitis will be evaluated by comparing each ultrasound to the criterion standard of computed tomography (CT) for each enrolled patient. If a CT is not obtained, then operative report/findings, discharge diagnosis or phone follow up at 2 weeks will be used as the criterion standard to which the ultrasound will be compared. Using the criterion standard as the definitive diagnosis for each patient (i.e. presence or absence of appendicitis), each ultrasound will be classified as a true positive, true negative, false positive or false negative. This data will be used to calculated the sensitivity, specificity, likelihood ratios, positive predictive value (PPV), negative predictive value (NPV) and accuracy of point-of-care ultrasound for the diagnosis of appendicitis.

  3 years

Secondary Outcomes (10)

• Intraabdominal Free Fluid

  3 years

• Dilated Loops of Bowel in RLQ

  3 years

• Appendicolith

  3 years

• Appendiceal Dilation

  3 years

• Appendiceal Wall Thickening

  3 years

Study Arms (1)

Ultrasound for Appendicitis

Emergency department patients undergoing point-of-care ultrasound to evaluate for suspected appendicitis

Procedure: Ultrasound for Appendicitis

Interventions

Ultrasound for Appendicitis PROCEDURE

Point-of-care ultrasound to evaluate emergency department patients for suspected appendicitis

Ultrasound for Appendicitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult and pediatric emergency department patients at a university-affiliated, community teaching hospital with suspected appendicitis

You may qualify if:

• RLQ pain with clinical suspicion for acute appendicitis

You may not qualify if:

• History of appendectomy
• Imaging prior to ED ultrasound performed to evaluate the RLQ
• Patients who are decisionally impaired or cannot provide consent

Sponsors & Collaborators

• WellSpan Health: lead
• Stony Brook University: collaborator

Study Sites (1)

Wellspan Health York Hospital

York, Pennsylvania, 17403, United States

Location

Related Publications (8)

• Burford JM, Dassinger MS, Smith SD. Surgeon-performed ultrasound as a diagnostic tool in appendicitis. J Pediatr Surg. 2011 Jun;46(6):1115-20. doi: 10.1016/j.jpedsurg.2011.03.040.

  PMID: 21683208 BACKGROUND

• Estey A, Poonai N, Lim R. Appendix not seen: the predictive value of secondary inflammatory sonographic signs. Pediatr Emerg Care. 2013 Apr;29(4):435-9. doi: 10.1097/PEC.0b013e318289e8d5.

  PMID: 23528502 BACKGROUND

• Fox JC, Solley M, Anderson CL, Zlidenny A, Lahham S, Maasumi K. Prospective evaluation of emergency physician performed bedside ultrasound to detect acute appendicitis. Eur J Emerg Med. 2008 Apr;15(2):80-5. doi: 10.1097/MEJ.0b013e328270361a.

  PMID: 18446069 BACKGROUND

• Hulley et al. Designing Clinical Reasearch. 4th ed. Philadelphia, PA: Lippincott, Williams & Wilkins; 2013: Chapter 6.

  BACKGROUND

• Karakas SP, Guelfguat M, Leonidas JC, Springer S, Singh SP. Acute appendicitis in children: comparison of clinical diagnosis with ultrasound and CT imaging. Pediatr Radiol. 2000 Feb;30(2):94-8. doi: 10.1007/s002470050023.

  PMID: 10663520 BACKGROUND

• Pacharn P, Ying J, Linam LE, Brody AS, Babcock DS. Sonography in the evaluation of acute appendicitis: are negative sonographic findings good enough? J Ultrasound Med. 2010 Dec;29(12):1749-55. doi: 10.7863/jum.2010.29.12.1749.

  PMID: 21098847 BACKGROUND

• Puylaert JB. Acute appendicitis: US evaluation using graded compression. Radiology. 1986 Feb;158(2):355-60. doi: 10.1148/radiology.158.2.2934762.

  PMID: 2934762 BACKGROUND

• Becker BA, Kaminstein D, Secko M, Collin M, Kehrl T, Reardon L, Stahlman BA. A prospective, multicenter evaluation of point-of-care ultrasound for appendicitis in the emergency department. Acad Emerg Med. 2022 Feb;29(2):164-173. doi: 10.1111/acem.14378. Epub 2021 Sep 14.

  PMID: 34420255 DERIVED

MeSH Terms

Conditions

Appendicitis; Emergencies

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Brent A Becker, MD

  Wellspan Health York Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Physician - Wellspan Health York Hospital

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 8, 2016
• Study Start: May 1, 2014
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)