Complication of Surgical Procedure, Postoperative Infection
Conditions
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.
Interventions
BEHAVIORALStandard Care
Previous standard of care based on surgeon judgement alone.
OTHERCALYPSO
Software platform of machine-learning based predictive models of surgical complication.
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Thirty Day Overall Complications | 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Complications | 30 days after surgery | Includes superficial, deep, organ space infections, and wound dehiscence |
| 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 |
| Thrombotic complications | 30 days after surgery | includes deep vein thrombosis, pulmonary emobolism |
| Renal Complications | 30 days after surgery | includes acute renal failure, renal failure requiring dialysis |
| Thirty Day Mortality | 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 | — |
| unplanned readmission | 30 days after surgery | — |
| bleeding complications | up to 72 hours after surgery | needing at least 1 unit of pRBC |
| urinary tract infections | 30 days after surgery | — |
Countries
United States
Outcome results
None listed