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

The First Affiliated Hospital of Anhui Medical University

Status: Completed

Conditions: High Risk Sex; Cardiac Disease

Treatments: Procedure: Brain oxygen saturation; Procedure: bispectral index; Other: Controlled; Procedure: mean artery pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03103633

FirstAnhuiM

Details and patient eligibility

About

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).

Enrollment: 286 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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286 participants in 2 patient groups

Individualized Goal-Directed Therapy

Experimental group

Description:

The goal of intervention:mean artery pressure 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.

Treatment:

Procedure: mean artery pressure

Procedure: bispectral index

Procedure: Brain oxygen saturation

Controlled

Sham Comparator group

Description:

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.

Treatment:

Other: Controlled