Supernormal Oxygen Delivery for Elderly Surgical Patients
- Conditions
- Femoral Fractures
- Interventions
- Procedure: SV maximizationProcedure: supernormal DO2
- Registration Number
- NCT02629250
- Lead Sponsor
- Guangzhou First People's Hospital
- Brief Summary
Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop more complications following major surgery. Quite a few researches have shown the benefits of goal-directed therapy (GDT) using fluid loading or inotropic agents or both to improve outcome during major surgery. However there is concern that inotropic therapy for a supernormal oxygen delivery (DO2I) may lead to an increased incidence of myocardial ischemia. Even though the meta-analysis has stated that DO2I strategy could possibly reduce the incidence of cardiac complication than stroke volume optimization strategy, there are very few evidence available in the literature regarding the effect on myocardial ischemia in surgical patients, especially in non-cardiac surgical patients. This study is undertaken to test the hypothesis that an intraoperative DO2I optimization result in a decreased myocardial ischemia in the elderly high-risk surgical patients.
- Detailed Description
Elderly patients with poor cardiopulmonary reserve tend to suffer higher risk and develop more complications following major surgery \[1\]. Quite a few researches have shown the benefits of goal-directed therapy(GDT) using fluid loading or inotropic agents or both to improve outcome during major surgery \[2-7\]. The maintenance of adequate tissue perfusion and global oxygen delivery (DO2I) is essential to maintain adequate tissue perfusion and oxygenation in relation to increased metabolic demand during high risk surgery. However, there is concern that inotropic therapy for a supernormal oxygen delivery may lead to an increased incidence of myocardial ischemia \[8\]. Even though the meta-analysis has stated that DO2I optimization could possibly reduce the incidence of cardiac complication than stroke volume optimization strategy \[9\],there are very few evidence available in the literature regarding the effect on myocardial ischemia in surgical patients, especially in non-cardiac surgical patients. This study is undertaken to test the hypothesis that an intraoperative DO2I optimization result in a decreased myocardial ischemia in the elderly high-risk surgical patients. The investigators will conduct a prospective, randomized, controlled, double-blinded trial in seventy patients who scheduled for proximal femur surgery under General anesthesia following nerve block. Both the patients will be allocated to one of two equal groups to receive either intraoperative fluid regimen guided by SV strategy or DO2I strategy. In the control(SV) group, the patients will receive an intravenous infusion of 250 ml Ringer's lactate solution in 5 min as a fluid challenge for stroke volume maximization. In the experimental(DO2I) group, fluid and dobutamine will be given to reach a stroke volume maximization and supernormal oxygen delivery. The primary outcome is preoperative and 24h postoperative serum concentration of troponin T. Secondary outcomes include the incidence of tachycardia, arrhythmia, myocardial infarction, pneumonedema and acute heart failure, blood pressure, pulmonary infection, fluid volume, blood transfusion volume, renal function, PONV, Length of postoperative hospital stay and mortality. Data will be collected and recorded by the clinical teams who are blind to study arm allocation.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- Adult patients scheduled for proximal femur fracture (PFF) surgery at this institution
- American Society of Anaesthesiologists (ASA) physical status of III or VI
- Two or more risk factors according to risk index of Lee
- Patient age < 70 yrs
- Ongoing myocardial infarct or ischemia
- Chronic haemodialysis
- Inability to cooperate in the study
- Patient refusal
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SV maximization SV maximization Goal-directed fluid therapy with stroke volume maximization. Device: The Volume-View system from Edwards Co. supernormal DO2 supernormal DO2 Goal-directed fluid therapy with stroke volume maximization and supernormal oxygen delivery. Device: The Volume-View system from Edwards Co.
- Primary Outcome Measures
Name Time Method Change from baseline in concentration of troponin T at 24 hours postoperatively preoperative value and 24 hours postoperatively Intraoperative supernormal oxygen delivery strategy will reduce the changes in concentration of troponin T at 24 hours postoperatively.
- Secondary Outcome Measures
Name Time Method cardiac complication up to 24 hours postoperatively up to 24 hours postoperatively Occurrence of newly diagnosed arterial fibrilation ,severe arrhythmia,clinical signs of unstable angina, myocardial infarction,pulmonary edema or therapy-requiring cardiac failure.
fluid balance up to 24hours after surgery amount of fluids (ml) infused, amount of fluid losses
heart rate (HR) up to 24 hours postoperatively HR(beats/min), bradycardia (HR \< 50 beats/min), and tachycardia (HR \> 100 beats/min) will be recorded at the same time as BP recording.
blood transfusion volume up to 24 hours postoperatively amount of blood transfusion, amount of blood losses.
length of postoperative hospital stay 28 days postoperatively days from end of surgery to hospital discharge
mortality 28 days postoperatively mortality within 28 days after surgery
cardiac complication at 28 days postoperatively 28 days postoperatively Occurrence of newly diagnosed arterial fibrilation ,severe arrhythmia,clinical signs of unstable angina, myocardial infarction,pulmonary edema or therapy-requiring cardiac failure.
incidence of pulmonary infection up to 28 days postoperatively number of patients having pulmonary infection requiring intravenous antibiotic therapy
blood pressure up to 24 hours postoperatively Invasive arterial BP(mmHg) is measured through an arterial line at the arm.episode of hypotension (30% decrease in mean BP in relation to baseline values) and hypertension (30% increase in mean BP in relation to baseline values) will be recorded.
SpO2 up to 24 hours postoperatively SpO2(%) and hypoxemia (SpO2 \<90%) will be recorded at the same time as BP recording.
Postoperative Nausea and Vomiting (PONV) 24 hours postoperatively Postoperative Nausea and Vomiting, The incidence of PONV will be recorded using a 4-point objective score (1 = no PONV;2 = mild nausea, no vomiting; 3 = excessive nausea or vomiting;4 = vomiting ≥2 times).
Acute Kidney Injury up to 24 hours postoperatively perioperative and 24h postoperative urine volume, serum creatinine, blood urea nitrogen.
Trial Locations
- Locations (1)
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China