Integration of Minimal Invasive Cardiopulmonary Bypass System and the Research of Its Blood Compatibility
Integration of Minimal Invasive Cardiopulmonary Bypass System and the Research of Its Blood Compatibility
Research objective:

 (1) To develop a minimally invasive extracorporeal circulation integrated system, and to form
 a new product package, the package of the system should include the extracorporeal
 circulation off-set supplies for a routine heart operation.(2) To explore the influence of
 integrated minimally invasive extracorporeal circulation system on the recent clinical
 outcome of patients.(3) To explore the influence of integrated minimally invasive
 extracorporeal circulation system on blood dilution of patients.(4) To explore the influence
 of integrated minimally invasive extracorporeal circulation system on inflammatory response
 in patients.

 1) Clinical research methods: A prospective, single-blind, randomized controlled study was
 designed. 80 patients should be included.Clinical study grouping: The control group was
 conventional cardiopulmonary bypass (CCPB) group, which was equipped with ordinary
 oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group was
 minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic
 oxygenator and mini cardioplegia (MP) formula (15ML15% potassium chloride (KCl)+10ml compound
 potassium, calcium and magnesium +25ml normal saline).

 Research method:

 A: Before, in, and after cardiopulmonary bypass (CPB) blood collection, Hemoglobin (Hb),
 hematokrit (Hct), and blood lactate values of the two groups of patients were measured and
 analyzed statistically.B: Blood transfusion volume, urine volume and ultrafiltration volume
 were collected during CPB in the two groups of patients, and the data of the two groups were
 statistically analyzed.To investigate the effects of integrated minimally invasive
 extracorporeal circulation system on inflammatory response indicators white blood cell count
 (WBC),C-reactive protein (CRP), interleukin-6(IL-6), tumor necrosis factor-a (TNF-a) and C3a
 in patients before (T0), CPB (T1) and 2 hours(H) after CPB (T2), blood samples were collected
 from the two groups, centrifugated, superfluid was taken, and stored at -80℃.The
 concentrations of CRP, IL-6, TNF-a and C3a were determined by ELISA.Statistical analysis was
 performed.WBC was measured in blood routine.(3) To investigate the influence of integrated
 minimally invasive extracorporeal circulation system on the recent clinical outcome of
 patients. The mechanical ventilation time, ICU time, length of hospital stay, and in-hospital
 mortality of patients in the two groups were statistically analyzed.
Research objective:

 (1) To develop a minimally invasive extracorporeal circulation integrated system, and to form
 a new product package, the package of the system should include the extracorporeal
 circulation off-set supplies for a routine heart operation.(2) To explore the influence of
 integrated minimally invasive extracorporeal circulation system on the recent clinical
 outcome of patients.(3) To explore the influence of integrated minimally invasive
 extracorporeal circulation system on blood dilution of patients.(4) To explore the influence
 of integrated minimally invasive extracorporeal circulation system on inflammatory response
 in patients.

 Research and development of integrated minimally invasive extracorporeal circulation system

 (1) Appropriate CPB tubes should be determined according to clinical needs. Adopt 3/8 inch
 vein tubes and elevate the position of blood storage tank to reduce the length of the tubes
 and precharge.The piping jacket shall include the main pump pipe, the infusion pipe, the
 platform package (static and static vessels), the left and right core suction pipe, and the
 negative pressure suction pipe.The total precharge should be kept at about 800ml (284ml
 static precharge of the self-equipped micro-plug oxygenator, and about 500ml precharge of the
 pipeline and stopping liquid perfusion system).(2) Cooperate with integrated membrane
 oxygenator manufacturers in the design of pipelines to form a wrapper that integrates
 membrane oxygenator and pipeline.Among them, oxygenator and pipeline should be well connected
 in the sheath.

 Clinical research methods:

 A prospective, single-blind, randomized controlled study was designed. 80 patients should be
 included.Clinical study grouping: The control group was CCPB group, which was equipped with
 ordinary oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group
 was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15ML15% KCl+10ml
 compound potassium, calcium and magnesium +25ml normal saline).

 Research method:

 A: Before, in, and after CPB blood collection, Hb, Hct, and blood lactate values of the two
 groups of patients were measured and analyzed statistically.B: Blood transfusion volume,
 urine volume and ultrafiltration volume were collected during CPB in the two groups of
 patients, and the data of the two groups were statistically analyzed.To investigate the
 effects of integrated minimally invasive extracorporeal circulation system on inflammatory
 response indicators WBC, CRP, IL-6, TNF- and C3a in patients before (T0), CPB (T1) and 2
 hours after CPB (T2), blood samples were collected from the two groups, centrifugated,
 superfluid was taken, and stored at -80℃.The concentrations of CRP, IL-6, TNF- and C3a were
 determined by ELISA.Statistical analysis was performed.WBC was measured in blood routine.(3)
 To investigate the influence of integrated minimally invasive extracorporeal circulation
 system on the recent clinical outcome of patients. The mechanical ventilation time, ICU time,
 length of hospital stay, and in-hospital mortality of patients in the two groups were
 statistically analyzed.
Inclusion Criteria:

 -  Patient weight ≤60kg;

 -  Age ≥18 years old;

 -  The patient underwent cardiac arrest surgery.

 Exclusion Criteria:

 -  Heart transplant patients;

 -  Emergency cardiac surgery patients;

 -  Patients who had been assisted by extracorporeal membrane oxygenator (ECMO) or
 assisted by left heart before operation

 -  Left ventricular ejection fraction (LVEF) < 30%;

 -  Patients with coagulation dysfunction before surgery;

 -  Patients with preoperative hepatic and renal insufficiency;

 -  Recent cerebrovascular accident patients.