Non-cardiac Surgery, Non-neurosurgical Surgery, Perioperative Adverse Events, Peri-operative Stroke
Conditions
Keywords
Peri-operative stroke, incidence, risk factors, prospective
Brief summary
Stroke is an important cause of perioperative morbidity and mortality, particularly in patients \> 60 years. In cardiac, neurological and carotid surgery the incidence is known to be high (2.2-5.2%). However, little is known regarding perioperative stroke following other types of surgery including general, urological, orthopedic, thoracic and gynecological procedures. We therefore propose to undertake a multicenter, observational cohort study, to determine the current incidence of, the risk factors for, and outcome associated with perioperative stroke in patients undergoing non-cardiac and non-neurological surgery.
Detailed description
Patient population: Prospective cohort study of 10,000 adults undergoing non-cardiac, non-neurological surgery. Screening and enrollment: Consecutive patients undergoing (elective or emergency) non-cardiac, non-neurosurgical surgeries will be recruited. Monitoring, follow-up, and data collection: Usual treatment will be provided. Demographic details will be recorded. Patients will be visited regularly in hospital. Patient will be reviewed for neurologic deficit using the mNIHSS. Brain imaging will be performed to confirm stroke event. Follow-up at 30 days after discharge will be done to ascertain if there is any adverse outcome.
Interventions
None listed
Sponsors
Chinese Medical Association
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages Eligible for Study: 60 Years and older * Genders Eligible for Study: Both * Accepts Healthy Volunteers: No * Sampling Method: Probability Sample
Exclusion criteria
* hospital stay after surgery less than 3 days * not consent of the assessment * surgery canceled
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| perioperative stroke occurs during and within 30 days after surgery. | 30 days after suegery | The primary outcome is perioperative stroke occurs during and within 30 days after surgery. This is defined as cerebral infarction or hemorrhage on computer tomography or magnetic resonance scan, or new neurological signs (paralysis, weakness or speech difficulties) lasting more than 24 hours or leading to death. The mechanism of stroke will be classified using the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total mortality and other major vascular complications up until 30 days after surgery | 30 days after suegery | Secondary outcomes include total mortality and other major vascular complications up until 30 days after surgery: 1. Myocardial infarction is defined according to recent universal definition of myocardial infarction; 2. Nonfatal cardiac arrest is a successful resuscitation from either documented or presumed ventricular fibrillation or sustained ventricular tachycardia or asystole; 3. Pulmonary embolism; 4. Congestive heart failure is defined by both clinical and radiographic evidence; 5. Clinically significant atrial fibrillation is defined as atrial fibrillation that results in angina, congestive heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion; 6. Cardiac death: defined as any death with a cardiovascular cause, including deaths following a cardiovascular procedure, cardiac arrest, myocardial infarction, pulmonary embolus, stroke, hemorrhage, or deaths due to unknown cause. |
Countries
China
Contacts
Primary ContactYun Yue, MD
Backup ContactZhuonan Sun, MD
Outcome results
None listed