CALYPSO Pilot Study: Machine Learning Based Predictions of Surgical Complications

Complication of Surgical Procedure Clinical Trial

— CALYPSO  

Official title:

Pilot Study for a Clinical Analytical Platform for Surgical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828475
• Other study ID #: Pro00072563
• Status: Completed
• Start date: June 2016
• Est. completion date: February 2017

Study information

• Verified date: January 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Postoperative Infection

Intervention

Other:
• CALYPSO
Software platform of machine-learning based predictive models of surgical complication.

Behavioral:
• Standard Care
Previous standard of care based on surgeon judgement alone.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

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