Background: Intraoperative hypotension increases 30-day mortality and the risks of myocardial injury and acute renal failure. Patients with inadequate volume reserve before the induction of anesthesia are highly exposed. The identification of latent hypovolemia is therefore crucial. Ultrasonographic measurement of the inferior vena cava collapsibility index (IVCCI) is able to detect volume responsiveness in circulatory shock and growing evidence support the theory that higher IVCCI can predict intraoperative hypotension. The aim of the present study is to evaluate the potential benefit of an ultrasound-based protocol for preoperative fluid optimization. The investigators will perform a randomized-controlled study involving elective surgical patients. An ultrasound-based protocol (USP) arm and a conventional fluid therapy group (CFT) are to be formed. Ultrasound examinations will be performed twice in both groups: 2 hours and 30 minutes preoperatively. The inferior vena cava and the anterior lung fields will be scanned. In the USP group the participants will receive fluid therapy according to the ultrasonographic findings: high level of IVCCI and absence of signs of pulmonary edema will indicate fluid therapy. In the CFT group the attending anesthesiologist (blinded to the results of ultrasonography) will order fluid therapy on the basis of daily routine and clinical judgement. The investigators will evaluate the incidence of intraoperative hypotension (primary outcome), postoperative metabolic status and organ functions and the amount of the administered intravenous fluids in both groups.
A randomized-controlled study with 80 participants. The investigators will use computer-generated unpaired random allocation method to an ultrasound-based protocol (USP) group or to the conventional fluid therapy (CFT) group. Preoperative ultrasound examinations will be performed twice in both groups: 2 hours and 30 minutes preoperatively. The inferior vena cava and the lung fields (so called BLUE - Bedside Lung Ultrasound in Emergency - points: 2nd or 3rd intercostal space anterior, 5th-6th interspace anterior and posterior axillary line position) will be scanned. The collapsibility index (IVCCI) of the IVC is calculated, \>40 percent is considered 'high IVCCI'. Lung ultrasound (LUS) is evaluated as indicative for 'lung congestion' if symmetric anterior B-profiles (at least 3 B-lines in anterior lung fields) are detected. Baseline demographic (age, sex, height, weight) and comorbidity data (history of hypertension, chronic heart failure, coronary or cerebrovascular disease, respiratory illness e.g. COPD, past COVID, diabetes on insulin treatment) together with laboratory data (haemoglobin, creatinine, blood urea) are to be recorded. A standardized practice of monitoring and induction of general anesthesia will allow for the detection of immediate and early (first 10 minutes of anesthesia) hypotensive events. A follow up for 24 hours is necessary for evaluating the fulfillment of secondary endpoints. A semi-quantitative lung ultrasound after 24 hours will estimate lung aeration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
80
Protocol of the interventional group according to the ultrasonographic findings: Ultrasound scan 2 hours before surgery: IVCCI\>40 percent and absence of symmetric anterior 'B-profile' on the lung ultrasound indicate intravenous (IV) fluid therapy: 8 ml/kg of isotonic, balanced crystalloid infusion. IVCCI≤40 percent AND/OR symmetric anterior 'B-profile' contraindicates further IV fluid therapy. A 2nd ultrasound scan at 30 minutes before surgery: IVCCI\>40 percent and absence of symmetric anterior 'B-profile' on the lung ultrasound indicate further IV fluid therapy: 5 ml/kg of isotonic, balanced crystalloid infusion. IVCCI≤40 percent AND/OR symmetric anterior 'B-profile' contraindicates further IV fluid therapy.
Semmelweis University, Deparment of Surgery, Transplantation and Gastroenterology
Budapest, Hungary
Rate of hypotension associated to general anesthesia induction
mean arterial pressure \< 65 mmHg AND/OR ≥30 percent of decrease compared to baseline (before induction of anesthesia)
Time frame: first 10 minutes of anesthesia
Dose of preoperative fluid therapy (in millilitres)
intravenous fluid therapy before anesthesia induction
Time frame: preoperative time frame on the day of surgery
Dose fluid therapy of the operative day (in millilitres)
all intravenous fluid therapy on the day of surgery
Time frame: 24 hours
lactate level (mmol/l)
highest lactate level in mmol of an arterial blood sample
Time frame: 1st postoperative hour
base excess (mmol/l)
worst base excess level in mmol of an arterial blood sample
Time frame: 1st postoperative hour
urine output (millilitres/24 h)
summarized urine output after surgery
Time frame: 24 hours
lung ultrasound score (LUS)
Summarized lung ultrasound score of 12 fields of the thorax (0-36 pts)
Time frame: 24th postoperative hour
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