Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dalhousie University | OTHER |
| Harvard University | OTHER |
| University of Toronto | OTHER |
| University of Ottawa |
Not provided
Not provided
Not provided
Not provided
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.
Lay Summary
Introduction: The World Health Organization estimates that 270-360 million operations are performed every year worldwide. Death and complications after surgery are a big challenge. In Canada, out of every 1000 major surgeries, 16 patients die in hospital after surgery. In the United States, for every 1000 operations, 67 patients unexpectedly need life support in the Intensive Care Unit. With population aging and limited resources, strategies to improve health after surgery are ever more important.
Vital signs, such as blood pressure and heart rate, show how the body is doing. Vital signs change during surgery because of patient, surgical, and anesthetic factors. Anesthesiologists can change vital signs with medications. However, medical professionals are only starting to understand which, and what ranges of, vital signs under anesthesia are associated with better health. Machine learning is a tool that can provide new ways to understand data. With better understanding, medical professionals can work to improve outcomes after surgery.
Objective: This study will analyze vital signs during surgeries for their links to death, complications (heart, lung, kidney, brain, infection), Intensive Care Unit admission, length of hospital stay, and hospital readmission. This study will determine which, and what levels of, vital signs may be harmful. The investigators predict that blood pressure, heart rate, oxygen level, carbon dioxide level, and the need for medications to change blood pressure will interact to be associated with death after surgery.
Methods: After obtaining Research Ethics Board approval, the investigators will analyze data from all patients who are at least 45 years old and had an operation (with the exception of heart surgery) with an overnight stay at the Queen Elizabeth II health centre (Halifax, Canada) from January 1, 2013 to December 1, 2017. There are approximately eligible 35,000 patients. The investigators will use machine learning to model the data and test how well our model explains outcomes after surgery.
Significance: 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. A better understanding of the impact of vital signs during surgeries may unveil methods to improve outcomes and resource allocation after surgery. The results may suggest ways to identify high-risk patients who should be monitored more closely after surgery. If the model performs well, it may motivate other researchers to use machine learning in health data research.
Please see full protocol for details.
May 2020 update (prior to dataset aggregation and analysis)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | 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 will be included. Patients under going cardiac surgery or deceased organ donation will be excluded. Patients without an electronic anesthetic record during surgery will also be excluded. Preliminary analysis of the intraoperative database estimates approximately 35,000 patients in this cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood pressure | Other | Systolic Blood Pressure (SBP)
Mean Arterial Pressure (MAP)
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All-cause postoperative mortality (yes/no) | 30 days after date of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| In-hospital Morbidity: Cardiac |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
For data analysis in summer 2019, we have access to mortality data up to December 31, 2017. We chose December 1, 2017, as the last surgery date to be included, to allow for a complete data set 30 days after surgery. January 1, 2013 was chosen to obtain a study period of 5 years.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35996071 | Derived | Ke JXC, McIsaac DI, George RB, Branco P, Cook EF, Beattie WS, Urquhart R, MacDonald DB. Postoperative mortality risk prediction that incorporates intraoperative vital signs: development and internal validation in a historical cohort. Can J Anaesth. 2022 Sep;69(9):1086-1098. doi: 10.1007/s12630-022-02287-0. Epub 2022 Aug 22. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2020 |
Not provided
| OTHER |
Not provided
Not provided
Not provided
|
| Heart rate | Other |
|
|
| Use of hemodynamic medications (i.e. special medications for blood pressure) | Other |
|
|
| Oxygen saturation by pulse oximetry (SpO2) | Other |
|
|
| End-tidal Carbon dioxide (EtCO2) | Other |
|
|
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 |
| 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 |
| In-hospital Morbidity: Acute Kidney Injury | Acute Kidney Injury (yes/no) | 30 days after date of surgery |
| In-hospital Morbidity: Cerebrovascular | Composite of strokes and transient ischemic attacks (yes/no) | 30 days after date of surgery |
| In-hospital Morbidity: Delirium | Delirium (yes/no) | 30 days after date of surgery |
| In-hospital Morbidity: Septic Shock | Septic Shock (yes/no) | 30 days after date of surgery |
| Postoperative ICU admission | ICU admission (yes/no) | 30 days after date of surgery |
| 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 |
| Hospital readmission | Hospital readmission (yes/no) | 30 days after date of surgery |
| Intraoperative mortality | Intraoperative mortality (yes/no) | 30 days after date of surgery |
| Days alive and out of hospital at 30 days postoperatively | Number of days | 30 days after date of surgery |
| Jun 24, 2020 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| D006339 | Heart Rate |
| D000089382 | Oxygen Saturation |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D008660 | Metabolism |
Not provided
Not provided