Angina Pectoris, Myocardial Infarction
Conditions
Keywords
remote ischemic conditioning, orthopedic surgery, ischemic heart disease
Brief summary
The investigators attempt to investigate the organ protective effect of remote ischemic conditioning in patients undergoing non-cardiac surgery with history of ischemic heart disease.
Detailed description
When adult patients with ischemic heart disease undergo non-cardiac surgery, perioperative ischemic complication may occur. These morbidity results in poor clinical outcomes. The incidence of perioperative myocardial ischemic event has been reported to be up to 19.7%. Remote ischemic preconditioning (RIPC) is a concept that a brief ischemic reperfusion of upper or lower extremity can transfer protection to the other vital organs from sustained ischemic reperfusion injury. Although RIPC is extensively studied in high risk cardiovascular surgery, it has not been tested in a non-cardiac surgery patients with a history of ischemic heart disease. Major organ injury including heart, lung and kidney will be evaluated in this randomized controlled trial.
Interventions
PROCEDURERemote ischemic preconditioning
three cycles of ischemia (5 min) / reperfusion (5 min) of available upper or lower limb with an automated machine using blood pressure cuff
PROCEDURESham control
The patients had the same pneumatic cuff around the upper arm and similar maneuvers were performed, but pressure was not applied to the cuff.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults patients who undergo orthopedic surgery with duration of longer than one hour * Patients with a history of ischemic heart disease (stable or unstable angina, myocardial infarction) * American Society of Anesthesiology (ASA) Physical Status Classification of 1, 2, or 3
Exclusion criteria
* Peripheral vascular disease involving upper or lower extremity * Orthopedic surgery which uses the tourniquet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Troponin-I | postoperative day one |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury | postoperative 48 hours | Acute kidney injury determined by AKIN criteria |
| ST-II segment analysis by Electrocardiography | every 30 minutes during surgery | — |
| Oxygenation index (PaO2/FiO2) | 5 minutes after anesthesia induction | — |
| length of hospital stay | up to 24 week | length of hospital stay |
| length of ICU stay | up to 24 week | length of ICU stay |
| Cardiac enzyme blood level (Creatinine Kinase, Creatinine Kinase -Myocardial Band) | immediate postoperative | — |
| Postoperative incidence of pneumonia | up to 24 week | Postoperative incidence of pneumonia |
| Postoperative incidence of myocardial ischemic event | up to 24 week | Postoperative incidence of myocardial ischemic event |
| Troponin-I | immediate postoperative | — |
| Creatinine | Immediate Postoperative | — |
| Postoperative wound infection | up to 24 week | Postoperative wound infection |
Countries
South Korea
Outcome results
None listed