CALYPSO Pilot Study: Machine Learning Based Predictions of Surgical Complications

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

Detailed Description
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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.

Official Title
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Pilot Study for a Clinical Analytical Platform for Surgical Outcomes

Conditions
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Complication of Surgical Procedure, Postoperative Infection

Intervention / Treatment
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* Other: CALYPSO
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CALYPSO-augmented<br>Patients' postoperative care will be augmented with the CALYPSO platform. | Other: CALYPSO<br>* Software platform of machine-learning based predictive models of surgical complication.<br>Behavioral: Standard Care<br>* Previous standard of care based on surgeon judgement alone.<br>|
| Historical Control<br>Patients' postoperative care was performed using standard practice, before adopting the CALYPSO platform | Behavioral: Standard Care<br>* Previous standard of care based on surgeon judgement alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thirty Day Overall Complications |  | 30 days after surgery | 

Secondary Outcome Measures

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