Surgery Clinical Trial
Official title:
Machine Learning Modeling of Intraoperative Hemodynamic Predictors of 30-day Mortality and Major In-hospital Morbidity After Noncardiac Surgery: a Retrospective Population Cohort Study
NCT number | NCT04014010 |
Other study ID # | 1024251 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2013 |
Est. completion date | December 31, 2017 |
Verified date | June 2020 |
Source | Nova Scotia Health Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
With population aging and limited resources, strategies to improve outcomes after surgery are ever more important. There is a limited understanding of what ranges of hemodynamic variables under anesthesia are associated with better outcomes. This retrospective cohort study will analyze how hemodynamic variables during surgeries predict mortality, morbidity, Intensive Care Unit admission, length of hospital stay, and hospital readmission. The use of machine learning in a large, broad surgery population dataset could detect new relationships and strategies that may inform current practice, and generate ideas for future research.
Status | Completed |
Enrollment | 35000 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - All patients ages = 45 receiving their index (i.e. first) non-cardiac surgery with an overnight stay at the Nova Scotia Health Authority Queen Elizabeth II (QEII) hospitals (Victoria General and Halifax Infirmary) Halifax, Canada, from January 1, 2013 to December 1, 2017. - For patients who had multiple surgeries, only the first non-cardiac surgery with an overnight stay at QEII will be included to avoid confounding from previous surgical admissions (i.e. one surgical admission per patient). Exclusion Criteria: - No intraoperative anesthetic records - Cardiac surgery patients - Deceased organ donation |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janny Xue Chen Ke | Dalhousie University, Harvard University, University of Ottawa, University of Toronto |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | All-cause postoperative mortality (yes/no) | 30 days after date of surgery | |
Secondary | In-hospital Morbidity: Any | Any complications in terms of cardiac, respiratory, renal, cerebrovascular, delirium, or septic shock (yes/no) | 30 days after date of surgery | |
Secondary | In-hospital Morbidity: Cardiac | Composite of acute myocardial infarction, cardiac arrest, ventricular tachycardia, congestive heart failure, pulmonary edema, complete heart block, shock excluding septic shock (yes/no) | 30 days after date of surgery | |
Secondary | In-hospital Morbidity: Respiratory | Composite of pneumonia, pulmonary embolism, acute respiratory failure, respiratory arrest, Mechanical Ventilation >= 96 hours (yes/no) | 30 days after date of surgery | |
Secondary | In-hospital Morbidity: Acute Kidney Injury | Acute Kidney Injury (yes/no) | 30 days after date of surgery | |
Secondary | In-hospital Morbidity: Cerebrovascular | Composite of strokes and transient ischemic attacks (yes/no) | 30 days after date of surgery | |
Secondary | In-hospital Morbidity: Delirium | Delirium (yes/no) | 30 days after date of surgery | |
Secondary | In-hospital Morbidity: Septic Shock | Septic Shock (yes/no) | 30 days after date of surgery | |
Secondary | Postoperative ICU admission | ICU admission (yes/no) | 30 days after date of surgery | |
Secondary | Prolonged Postoperative Length of Stay (LOS) | Greater than vs. less than or equal to Canadian Institute of Health Information Expected Length of Stay (ELOS) as assigned by the Case Mix Grouping | 30 days after date of surgery | |
Secondary | Hospital readmission | Hospital readmission (yes/no) | 30 days after date of surgery | |
Secondary | Intraoperative mortality | Intraoperative mortality (yes/no) | 30 days after date of surgery | |
Secondary | Days alive and out of hospital at 30 days postoperatively | Number of days | 30 days after date of surgery |
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