Cardiac Disease, High Risk Sex
Conditions
Keywords
oxygen dynamics, Prognosis
Brief summary
Anesthesia-related factors have been linked to poor perioperative outcomes. Our observational study suggested that the cumulative duration of a triple-low state \[intraoperative low mean arterial pressure (MAP), low bispectral index (BIS), and low target effect-site concentration(Ce) \]was associated with poorer 30-day mortality.This randomized, prospective study based on individualized Oxygen dynamics is designed to confirm this association in high-risk patients cardiopulmonary bypass (CPB).
Interventions
PROCEDUREmean artery pressure
mean artery pressure declined with less than 20% of baseline
PROCEDUREbispectral index
BIS 45-60 before and after CPB; and BIS 40-45 during CPB
PROCEDUREBrain oxygen saturation
Brain oxygen saturation declined with less than 20% of baseline
OTHERControlled
receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients were followed up by an investigator unaware of the patients' achievement or not of the oxygen dynamic goal
Intervention model description
Interventional group:MAP declined with less than 20% of baseline, BIS 45-60 before and after CPB; and BIS 40-45 during CPB, Brain oxygen saturation declined with less than 20% of baseline. Control group：no intervention beside the same monitoring with MAP, BIS and brain oxygen saturation and receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent; 2. Selective cardiac surgery and general anesthesia patients; 3. Age 18-90 yrs; 4. Anesthesia Society of American (ASA) Scale II-IV 5. European System for Cardiac Operative Risk Evaluation score equal to or greater than 6 or left ventricular ejection fraction lower than 50%
Exclusion criteria
1. Preoperative cardiac ejection fraction\<30 %; 2. History of anesthesia awareness; 3. History or anticipation of difficult intubation; 4. Unanticipated intraoperative conditions, including haemorrhage, obstinate resuscitation failure,multiple cardiopulmonary bypass procedures, severe hypotension or hypoxemia; 5. long-term preoperative use of anticonvulsant agents, opiates, benzodiazepines or cocaine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1,3,5-year mortality | 1,3,5-year after surgery | Data for duration of 1,3,5-year all-cause mortality is extracted after 1-year follow-up |
| Major postoperative complications(i.e., Rate of low cardiac output syndrome, stroke, myocardial ischemia, infection,reoperation, and need for dialysis) | 30-day after surgery | Number of Participants with major complications extracted after 30-day follow-up |
| 30-day mortality | 30-day after surgery | Data for duration of postoperative 30-day all-cause mortality |
| The change of incidence of postoperative delirium | The 1,2,3 day after surgery | Through Confusion Assessment Method (CAM)to assess the incidence of the postoperative delirium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative hospital stay | 30-day after surgery | Data for duration of postoperative hospital stay is extracted after 30-day follow-up |
| The change of incidence of postoperative cognition dysfunction | 1 day before surgery, the 3,7 day after the surgery | The neuropsychological tests performed at the day before the surgery,the 3,7 day after the surgery respectively. |
| The occurrence of cardiovascular events | 30-day after surgery | Data for duration of the occurrence of cardiovascular events is extracted 30-day follow-up |
| The incidence of any adverse events | 30-day after surgery | Including kidney or brain related adverse events 30-day after surgery |
Countries
China
Outcome results
None listed