Category
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Primary study
Registry of Trials»Registro Público Cubano de Ensayos Clínicos
Year
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2019
Links
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INTERVENTION: Clinical Protocols Group I ‐ Enhanced Recovery After Surgery protocol (Experimental): Protocol actions are: 1. Nutrition screening and optimization must be done during preoperative period, if the patient have bad nutritional status (taking in to consideration body mass index less than 18.5 Kg/m2 , weigh lost more than 10% in the last 6 month, decreases in oral intake more than 50% in one week, albumin level less than 3 g/dL, lymphocytes account level less than 1 000 cells / mm3 (20 %) ; he will be send to nutritional specialist for correct optimization 2. Clinical optimization: Correction of Hemoglobin level: more than 12 g/dl for women and 13 g/dl for men. Respiratory physiotherapy one week previous surgery. Stop smoking and intake alcohol 4 weeks previous surgery. 3. Avoid bowel preparation. 4. The fasting time for solid food will be 6 hr 5. The fasting time for liquid will be 3 hr. The patients will receive 250 ml of Nutrial II (solution with high content of carbohydrates) 6. Preoperative education: All patient will received detailed explanation about perioperative pathways and educational brochure will be delivered. Intraoperative actions 1. Prophylactic antibiotic: cefuroxime 1.5 g, 60 min previously to the surgery. 2. Multimodal anesthesia/analgesic techniques, with a combination of general anesthesia, intercostal block and wound infiltration at the end of the surgery. Preventive analgesia: Gabapentin two hour previously to the surgery. Perfalgan 15 mg /kg of corporal body. 3. Lung protection strategy: low tidal volume (6‐7 ml/kg), positive end expiratory pressure (5 mmhg) and alveolar recruitment manoeuvres. 4. Intraoperative goal‐directed therapy (GDT) will be introduced to achieve total negative balance between 250 and 500ml. 5. Optimization of cardiopulmonary bypass: Total priming fluid reduction to less than 1500 ml, ultrafiltration and albumin infusion to maintain a stable plasma colloid osmotic pressure. 6. The Post‐Operative Nausea and Vomiting (PONV) prophylaxis wi Peri‐operative care protocol CONDITION: Coronary Artery Disease Coronary artery disease, valvular and aortic diseases INCLUSION CRITERIA: 1. Obtain Informed consent 2. Patient without prior cardiac surgery. 3. Functional classification by NYHA or Canadian society in grade I, II or III. 4. Cardiac ejection fraction more than 45 %. 5. Absent of symptomatic arrhythmias. 6. Alert and without neurological dysfunction. 7. Urinary output more than 0.5 ml/Kg body weight, with creatinin level less than 132 mmol/l. 8 Absent of lung congestion sing in the thoracic X‐ray. PRIMARY OUTCOME: 1. Perioperative complications (immediate and mediated intraoperative and postoperative). Measurement time: 30 days after surgery. For this, they will be measured as: Intraoperative (Complications that arise from the beginning of the anesthetic procedures until the patient,is transferred to the ICU after the operation), Immediate postoperative (Complications that occur from the moment the patient arrives at the ICU until the first 72 hours after the surgical intervention), Postoperative mediations (Complications that occur from 72 hours after the surgery and until the patient is discharged from hospital) and Late postoperative (Complications that occur from hospital discharge up to 30 days after the surgical procedure) 2. Stay in the Intensive Care Unit (Time, measured in hours, from the entrance to the Intensive Care Unit (ICU) until the exit from the ICU). Measurement time: Upon discharge from the ICU 3. Hospital stay (Time, measured in days, from the date of entry to the ward until hospital discharge). Measurement time: at hospital discharge SECONDARY OUTCOME: 1. Adherence to the ERAS protocol (If when 75% (15 of 21) of the recommended actions in the study group are met). Measurement time: 72 hours after surgery. 2. Orotracheal extubation time (Time elapsed, in hours, from the end of the surgical intervention until the orotracheal extubation). Measurement time: At orotracheal extubation 3. Enteral nutrition time (Time elapsed, in hours, from the end of the surgical intervention until the oral feeding route is established). Time: at the time of establishing oral feeding. 4. Total intraoperative‐BHTI and postoperative‐BHTP water balance (Amount of volume, quantified in milliliters, to be administered to the patient during the intraoperative and postoperative periods). Measurement time: at the end of the intraoperative and postoperative periods 5. Time of postoperative mobilization‐TMP (Time elapsed, in hours, from the end of the surgical intervention until the patient is seated). Measuring time: when the patient sits 6. Postoperative analgesia (Intensity of pain, evaluated verbally, according to visual analog scale (VAS) from zero to ten points). Measurement time: after the patient has been extubated, on an hourly basis, in the first three hours, at six hours, 12 hours, 24, 48 and 72 hours. 7. Opioid consumption (Total dose of opioids (mg) intravenously, which is needed in each patient to achieve adequate analgesia during the perioperative period). Measurement time: at the end of the perioperative period 8. Inotropic drug use (Yes, No. As required inotropic drugs to achieve hemodynamic stability). Measurement time: Upon discharge from the ICU 9. Early hospital readmission (Yes, No. As required by a re‐entry of the patient after hospital discharge, for any reason). Measurement time: 30 days after surgery. 10. Level of satisfaction (High if the affirmative answers to the questions are between 90 and 100%, Quite satisfied if the affirmative answers to the questions are between 80 and 89%, Satisfied if the affirmative answers to the questions are between 70 and 79% and, not satisfied if the affirmative answers to the questions are less than 70%). Measurement time: 30 days after surgery.
Epistemonikos ID: feaab9375d28170b850134cb205fb8ae93b137b7
First added on: Aug 24, 2024