Cardiac Surgery Clinical Trial
Official title:
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.
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