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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06395636
Other study ID # IRB 2024-6701
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date July 31, 2027

Study information

Verified date June 2024
Source Ann & Robert H Lurie Children's Hospital of Chicago
Contact Fizan Abdullah, MD, PhD
Phone 312-227-4210
Email fabdullah@luriechildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to analyze Fitbit data to predict infection after surgery for complicated appendicitis and the effect this prediction has on clinician decision making.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date July 31, 2027
Est. primary completion date January 1, 2027
Accepts healthy volunteers No
Gender All
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria: - children aged 3-18 years - must be post-surgical laparoscopic appendectomy for complicated appendicitis (Appendicitis is categorized as complicated if perforation, phlegmon, or abscess was present at surgery.) Exclusion Criteria: - children who are non-ambulatory or have any pre-existing mobility limitations - children who have a doctor-ordered physical activity limit >48 hours post-surgery - children who have a comorbidity which will impact a patient's recovery - children and/or parents who do not speak English or Spanish (Translation services beyond Spanish will not be available at this time)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Infection-Prediction Algorithm
This machine learning algorithm will be developed(Aim1a) and validated(Aim 1b) using the participant Fitbit data and survey results collected during Aim 1. In Aim 2 the algorithm will be used in real time to predict postoperative infection.

Locations

Country Name City State
United States Ann & Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States Northwestern University (Feinberg School of Medicine, Shirley Ryan AbilityLab) Chicago Illinois
United States Loyola University Medical Center Maywood Illinois
United States Northwestern Medicine Central DuPage Hospital Winfield Illinois

Sponsors (5)

Lead Sponsor Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago Central DuPage Hospital, Loyola University Chicago, Northwestern University, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trends in Participant Fitbit Data (Physical Activity, Heart Rate, Sleep) during the Recovery Period post Complicated Appendectomy Participant Fitbit data metrics (particularly PA, HR, Sleep) will be extracted from the app and analyzed using Machine Learning methods to eventually develop an algorithm to predict infection during the postoperative recovery period. Fitbit data metrics will be collected for 30 days starting at date of enrollment.
Secondary Number of Reported Symptoms and Complications during Recovery Participants & Parents/Guardians will report any symptoms or complications that occur during the recovery period via a daily diary/survey. Daily Diary/Survey Submissions will be asked to be completed daily for 30 days starting day of enrollment.
Secondary Healthcare Utilizations during Recovery Period The daily diary/survey will also ask Parents / Guardians of any trips to the ER, readmissions, or hospital visits relating to the participant's appendectomy. The diary / survey will require a submission every day for 30 days starting at day of enrollment.
Secondary Change in Clinician Decision Making from Algorithm Results Clinicians of participants (Aim 2) will be asked if the results from the infection prediction algorithm had any impact on their clinical care decisions. For 30 days starting at day of participant enrollment
See also
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Recruiting NCT02108340 - Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis N/A
Terminated NCT02029781 - The Laparoscopic Appendicitis Score; a Multicenter Validation Study N/A
Completed NCT01356641 - Antibiotic Treatment Alone for Acute Simple Appendicitis in Children N/A
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Completed NCT01515293 - Single Incision Versus Conventional Laparoscopic Appendectomy Phase 3
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Completed NCT02916134 - Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis N/A
Completed NCT04614649 - Right Iliac Fossa Treatment-Turkey Audit
Completed NCT04365491 - European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
Completed NCT03770897 - Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome N/A
Completed NCT02507674 - Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study
Active, not recruiting NCT01718275 - Non-operative Management of Early Appendicitis in Children
Terminated NCT01575028 - Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies Phase 2