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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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Excessive fluid loss is often reported in gastrointestinal surgical patients due to preoperative fasting and bowel preparations. Insufficient fluid infusion may cause hypovolemia and tissue hypoperfusion, which may delayed postoperative recovery and even induce postoperative acute renal failure. The aim of this study is to compare the effects of Goal-directed fluid therapy (GDFT) strategy with that of the conventional fluid management on the morbidity and mortality of postoperative complications, length of postoperative hospital stay, and medical expense, so as to provide clinical evidences for optimized intraoperative fluid management for patients undergone gastrointestinal surgery.
I. Background Excessive fluid loss is often reported in gastrointestinal surgical patients due to preoperative fasting and bowel preparations. Many factors may further exacerbate the lack of fluid volume, including intraoperative blood loss and fluid loss, anesthetic drug-induced peripheral vasodilatation, as well as systemic inflammatory response syndrome, systemic capillary leak syndrome, endothelial barrier dysfunction and transfer of intravascular fluid to the third space caused by surgical trauma.
Insufficient fluid infusion may cause hypovolemia and tissue hypoperfusion, which may delayed postoperative recovery and even induce postoperative acute renal failure. On the other hand, fluid overload can lead to edema, increased oxygen diffusion distance between lung mesenchyme and cells, then causing tissue ischemia, hypoxia, and acidosis and even affecting the recovery of gastrointestinal function and the healing of incision. It has been proved that improper fluid therapy in the perioperative period is associated with poor outcomes in patients with gastrointestinal surgery. Goal-directed fluid therapy (GDFT) regimen emphasizes the personalized fluid infusion to optimize the intraoperative hemodynamics and tissue perfusion, including rising stroke volume, increasing arterial oxygen saturation, which may result in improving postoperative outcomes.
Flo-Trac/Vigileo system is developed by Edwards Technology, and monitors the continuous cardiac output via peripheral arteries. The monitoring approaches of this system prove to be convenient, safe and minimally invasive. As an important indicator of the system, stroke volume variation (SVV) can accurately reflect the volume status of patients. The principle of SVV is the preload change, which is caused by the intrathoracic pressure changes between inspiratory and expiratory phases, will lead to arterial pulse pressure fluctuations, thus affecting stroke volume (SV). SV may vary under different volume loads. Through measuring and analyzing these differences and then assessing the circulation status, SVV provides guidance for fluid therapy. The continuous and real-time SVV monitoring can provide data of patients' circulation status, thereby optimizing clinical fluid treatment options and avoiding excessive or insufficient volume. For patients with gastrointestinal surgery, SVV guidance during the surgery can accurately regulate fluid infusion, which will contribute to the early postoperative recovery and improve patient prognosis.
In the present study, SVV-directed fluid therapy will be performed in patients with gastrointestinal surgery and then will be compared with conventional fluid treatment regimen in the mobility and mortality of postoperative complications, postoperative recovery, and length of hospital stay. The investigators are aiming to provide clinical evidences for reasonable intraoperative fluid management of such patients.
II. Objectives The aim of this study is to compare the effects of GDFT strategy with that of the conventional fluid management on the morbidity and mortality of postoperative complications, length of postoperative hospital stay, and medical expense, so as to provide clinical evidences for optimized intraoperative fluid management for patients undergone gastrointestinal surgery.
III. Research Plan 1. Design: quantitative observational comparative effectiveness research. 2. Sample Volume: 200 cases of subjects in the experimental group and control group, respectively.
3. Research phases The research is divided into three phases
4. GDFT protocol
Anesthesia management The radial artery line is placed before anesthesia. The invasively arterial blood pressure, ECG, HR and SPO2 are monitored. The Flo-Trac/Vigileo monitoring system is connected with the radial artery line of the GDFT group, CO, SV, SVV and other hemodynamic parameters are monitored. In addition, the bispectral index (BIS) is continuously monitored to assess the depth of sedation.
Induction: 0.01~0.03 mg/kg of midazolam, 0.2~0.4μg/kg of sufentanil, 1~2 mg/kg of propofol and 0.6~0.9 mg/kg of rocuronium are injected intravenously for anesthesia induction. After the completion of endotracheal intubation, the internal jugular puncture catheterization is undergone at the right side to monitor the central vein pressure.
Maintenance: After endotracheal intubation, the mechanical ventilation is initiated. The tidal volume is set as 6~8 mL/kg, respiratory rate as 10 to 14 times/min and inhalation to exhalation ratio as 1:2. In the surgery, the partial pressure of carbon dioxide in end expiratory gas is kept at the level of 35 - 45 mmHg. And the remifentanil (target concentration of effect compartment is 4 - 8 ng / mL) and propofol (target concentration of plasma is 3 - 5μg / mL) of intravenous target-controlled infusion are given to maintain the anesthesia effect. BIS value is maintained at 40 - 50. Besides, 0.1~0.3μg/kg sufentanil and 0.1~0.2 mg/kg rocuronium are injected intermittently. About 30 minutes before the end of the surgery, a bolus of 0.1~0.3μg/kg sufentanil is administered.
Recovery: The depth of anesthesia is reduced gradually at the end of the surgery. In the recovery period, the atropine and neostigmine are given as muscle relaxant antagonists. Extubation is performed according to the awareness, breathing, muscle strength and reflex recovery of the patient. All patients are delivered to ICU after surgery.
Fluid Treatment Compensatory volume of expansion (CVE) is replaced with 5mL/kg of Ringer's lactate solution before induction. The maintained dose of infusion of crystalloid during surgery is: 2~4 ml/kg/h for open procedure (maximum dose of 400ml/h), and 1~2 ml/kg/h for laparoscopic procedure (maximum dose of 200ml/h) respectively. Fluid replacement is directed by SV value. After incision (after pneumoperitoneum for laparoscopic cases) give a 200 mL Hydroxyethyl Starch 130/0.4 and Sodium Chloride bolus over <10 min. If SV increases by >10%, repeat bolus until SV increases by <10%. Record peak value achieved. Give a further colloid bolus when SV drops 10% from peak value and repeat cycle. According to the bleeding, RBC and plasma are given if necessary. SaO2≥95%, Hb > 70g/L, core body temperature> 37 ℃, HR50 /min~100/min and MAP60~100mmHg are maintained during the surgery in both groups. When SBP<90 mmHg or MAP < 60 mmHg, the two groups are given the vasoactive drug of bitartrate noradrenaline.
5. Monitoring variables
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Before GDFM Training | About 200 patients' medical record information will be extracted from the 1st Affiliated Hospital of Chongqing Medical University electronic medical record prior to the start of the training curriculum. | ||
| After GDFM Training | About 200 patients' medical record information will be extracted from the 1st Affiliated Hospital of Chongqing Medical University electronic medical record after the training program took place |
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| Measure | Description | Time Frame |
|---|---|---|
| The difference in postoperative morbidity rate between pre-training and post-training cohorts | within postoperative 30 days | |
| The difference in postoperative mortality rate between pre-training and post-training cohorts | within postoperative 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of postoperative complications | within postoperative 30 days | |
| Postoperative length of hospital stay | within postoperative 30 days | |
| Readmission rate |
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Inclusion Criteria:
Exclusion Criteria:
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patients undergone gastrointestinal surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juying Jin, Doctor | Contact | +86-13527486171 | juyingjin@Hotmail.com | |
| Su Min, MD | Contact | +86-023-89011068 | ms89011068@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Su Min, MD | First Affiliated Hospital of Chongqing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | 400016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30305890 | Derived | Jin J, Min S, Liu D, Liu L, Lv B. Clinical and economic impact of goal-directed fluid therapy during elective gastrointestinal surgery. Perioper Med (Lond). 2018 Oct 4;7:22. doi: 10.1186/s13741-018-0102-y. eCollection 2018. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| within post-discharge 30 days |
| Time of flatus | within postoperative 30 days |
| Time of defecation | within postoperative 30 days |
| Time of urine catheter removal | within postoperative 30 days |