The Effects of Individualized Oxygen Dynamic on Prognosis of Patients With High-risk Cardiac Surgery

The First Affiliated Hospital of Anhui Medical University286 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

286

Conditions

Cardiac Disease High Risk Sex

Interventions

ControlledOTHER

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: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Major postoperative complications(i.e., Rate of low cardiac output syndrome, stroke, myocardial ischemia, infection,reoperation, and need for dialysis)

Number of Participants with major complications extracted after 30-day follow-up

Time frame: 30-day after surgery

30-day mortality

Data for duration of postoperative 30-day all-cause mortality

Time frame: 30-day after surgery

The change of incidence of postoperative delirium

Through Confusion Assessment Method (CAM)to assess the incidence of the postoperative delirium

Time frame: The 1,2,3 day after surgery

1,3,5-year mortality

Data for duration of 1,3,5-year all-cause mortality is extracted after 1-year follow-up

Time frame: 1,3,5-year after surgery

Secondary Outcomes

postoperative hospital stay

Data for duration of postoperative hospital stay is extracted after 30-day follow-up

Time frame: 30-day after surgery

The change of incidence of postoperative cognition dysfunction

The neuropsychological tests performed at the day before the surgery,the 3,7 day after the surgery respectively.

Time frame: 1 day before surgery, the 3,7 day after the surgery

The occurrence of cardiovascular events

Data for duration of the occurrence of cardiovascular events is extracted 30-day follow-up

Time frame: 30-day after surgery

The incidence of any adverse events

Including kidney or brain related adverse events 30-day after surgery

Time frame: 30-day after surgery

The Effects of Individualized Oxygen Dynamic on Prognosis of Patients With High-risk Cardiac Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes