The FloTrac/Vigileo is a minimal invasive device assessing flow based hemodynamic parameters by pulse contour analysis based on the radial artery pressure signal. This method gained popularity as it is minimally invasive compared to esophageal Doppler or pulmonary artery catheter insertion and provides continuous beat-to-beat data. The previous study with 110 patients found that that GDHT guided by stroke volume variation (SVV) using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of POGD in major abdominal oncological surgery. However, no difference was found in the incidence of postoperative complications between the two groups, lack of statistical power could be a limitation to demonstrate the true association. Therefore, further prospective trials are needed to address this issue. The use of early and efficient therapeutic strategies able to detect and to treat potential triggers of organ failures, such as tissue hypoperfusion, is particularly important. If hypoperfusion is not adequately managed, tissue hypoxia could occur, resulting from an impairment of the adaptive mechanisms of myocardial contractile function, under the influence of inflammatory mediators, and the peripheral tissues will then increase their oxygen extraction (O2ER). AS such, GDHT guided by O2ER may be appropriate to monitor GDHT strategies because it reflects the balance between oxygen delivery and consumption. Therefore, the investigators performed this single-center, randomized, controlled trial to investigate whether GDHT guided by SVV using FloTrac/Vigileo monitor and GDHT guided by O2ER would reduce incidence of postoperative complication and shorten the length of hospital stay, compared with a standard conventional fluid therapy in low-to-moderate risk patients undergoing major laparoscopic gastrointestinal oncological surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
610
GDHT guided by SVV using Flotra/Vigileo monitor
GDHT guided by O2ER
conventional fluid therapy without GDHT
postoperative complication
the number of patients with predefined moderate or major postoperative complications (pulmonary embolism, myocardial ischemia or infarction, arrhythmia, cardiac or respiratory arrest, limb or digital ischemia, cardiogenic pulmonary edema, acute respiratory distress syndrome, gastrointestinal bleeding, bowel infarction, anastomotic breakdown, paralytic ileus, acute psychosis, stroke, acute kidney injury, infection \[source uncertain\], urinary tract infection, surgical site infection, organ/space infection, bloodstream infection, nosocomial pneumonia, and postoperative hemorrhage
Time frame: 30 days after surgery
Length of hospital stay
Length of stay was determined by the period from completion of surgery to discharge
Time frame: from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery
critical care-freedays
numberof days alive and not in critical care
Time frame: 30 days after surgery
mortality
all cause mortality
Time frame: all-cause mortality at 30 days following surgery; all-cause mortality at 180 days following surgery
postoperative recovery quality
QoR15, 0 :not at all , 10: most of time
Time frame: 1, 3, 7 days after surgery
time to first tolerate of an oral diet
time from the end of surgery and first tolerate of an oral diet
Time frame: from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery
time to first flatus
duration between the end of surgery and first flatus
Time frame: from the end of surgery until the date of discharge from hospital,assessed up to 30 days after surgery
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