Coronary Artery Bypass Graft Triple Vessel
Conditions
Keywords
microcirculation, off-pump coronary artery bypass surgery, tissue oxygen saturation, vascular occlusion test, recovery slope
Brief summary
Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is important for clinical outcome. The investigators hypothesized that prewarming during induction of general anesthesia would reduce drop of body temperature and change of peripheral microcirculation.
Detailed description
Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare the recovery slope during vascular occlusion test between prewarming treatment group and control group.
Interventions
DEVICEprewarming
recovery slope StO2
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* off-pump coronary artery bypass surgery
Exclusion criteria
* refuse to enroll * cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula * preoperative left ventricular ejection fraction \< 35% * preoperative continuous infusion of vasopressor or inotropes * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Slope | 3 hours after induction of anesthesia | We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation. |
Secondary
| Measure | Time frame |
|---|---|
| Tissue Oxygen Saturation | During the surgery, an average of 4 hours |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prewarming prewarming during induction of anesthesia
prewarming: recovery slope StO2 | 20 |
| Control no prewarming during induction of anesthesia | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Control | Total | Prewarming |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 8 | 65 years STANDARD_DEVIATION 8 | 63 years STANDARD_DEVIATION 9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Korea, Republic of | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 16 Participants | 30 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Recovery Slope
We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.
Time frame: 3 hours after induction of anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prewarming | Recovery Slope | 2.8 % / sec (recovery slope unit) | Standard Deviation 1 |
| Control | Recovery Slope | 3.1 % / sec (recovery slope unit) | Standard Deviation 1.5 |
Secondary
Tissue Oxygen Saturation
Time frame: During the surgery, an average of 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prewarming | Tissue Oxygen Saturation | 76 % (percent of tissue saturation) | Standard Deviation 10 |
| Control | Tissue Oxygen Saturation | 79 % (percent of tissue saturation) | Standard Deviation 7 |