CALYPSO Pilot Study: Machine Learning Based Predictions of Surgical Complications

Completed

• Conditions: Postoperative Infection; Complication of Surgical Procedure

• Registration Number: NCT02828475
• Lead Sponsor: Duke University

Brief Summary

This is a pilot study of surgical patients whose postoperative care will be augmented with a personalized risk prediction platform (CALYPSO app).

Detailed Description

CALYPSO is a software platform that uses machine learning techniques to create personalized risk predictions for postoperative complications. Individual risk factors are then linked to best-practice interventions tailored to the individual patient. The investigator aims to test the hypothesis that using CALYPSO-augmented postoperative care will reduce complication rates in patients undergoing elective general surgery. Subjects undergoing surgery will be assigned to the CALYPSO intervention in the postoperative period.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-11
• Primary Completion: 2017-01
• Study Completion: 2017-02
• Status Verified: 2018-01
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• >18 years of age
• Undergoing elective surgery
• Undergoing high risk colon, rectal, pancreas, gastric surgery with predicted length of stay greater or equal to 3 days

Exclusion Criteria

• Surgeries with less than 3 days of anticipated length of stay (e.g. stoma takedown)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thirty Day Overall Complications	30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Renal Complications	30 days after surgery	includes acute renal failure, renal failure requiring dialysis
Thirty Day Mortality	30 days after surgery
Wound Complications	30 days after surgery	Includes superficial, deep, organ space infections, and wound dehiscence
Thrombotic complications	30 days after surgery	includes deep vein thrombosis, pulmonary emobolism
Cardiac Complications	30 days after surgery	includes myocardial infarction, cardiac arrest
Respiratory Complications	30 days after surgery	includes unplanned reintubation, pneumonia, failure to wean from ventilator \>48 hours after surgery
urinary tract infections	30 days after surgery
Neurologic complications	30 days after surgery	includes stroke, peripheral nerve injury, coma
Septic complications	30 days after surgery	includes sepsis and septic shock
Unplanned reoperation	30 days after surgery
bleeding complications	up to 72 hours after surgery	needing at least 1 unit of pRBC
unplanned readmission	30 days after surgery

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States