The investigators aimed to examine the effect of goal-directed fluid therapy (GDFT) compared to conventional fluid therapy in thoracoscopic lobectomy surgery with ERAS protocol on intraoperative pulmonary oxygenation and 30-day patient outcomes including postoperative morbidity and mortality. The primary outcome measure of the study was the PaO2/FiO2 ratio (change in pulmonary oxygenation) during one-lung ventilation, and the secondary outcomes were postoperative morbidity, quality of recovery, 30-day re-admission, and mortality rate. This randomized controlled study analyzed 80 adult patients who underwent thoracoscopic lobectomy surgery with the ERAS protocol. In addition to standard monitoring in the operating room, all participants underwent Pressure Recording Analytical Method (PRAM) monitoring with the help of intra-arterial pressure monitoring method. Participants were randomly assigned to GDFT and conventional fluid therapy groups. In the GDFT group, fluid, inotropic agent and/or vasopressor therapy was administered by targeting stroke volume variation (SVV) and cardiac index (CI). In the control group, fluid and/or vasopressor therapy was administered with the guidance of MAP 65-95 mmHg and urine output at least 0.5 mL/kg/hr. Intraoperative hemodynamic data, amount and types of fluid administered, inotropic and vasopressor agents were recorded. Vital signs, pulmonary, cardiac and other system morbidity, quality of recovery on days 1, 3 and 5 in the postoperative care unit and in the ward, and re-admission to hospital and mortality within 30 days were recorded.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
80
This arm administers fluid and vasopressor therapy based on SVV (less than 15%) and CI (\>2.6 L/min/m²) targets using the Pressure Recording Analytical Method (PRAM) system with the help of intra-arterial pressure monitoring method. Basal fluid replacement is provided with 5 mL/kg/hr of Lactated Ringer's solution.
This arm administers fluid and vasopressor therapy based on targets of Mean Arterial Pressure (MAP) 65-95 mmHg and hourly urine output minimum of 0.5 mL/kg/hr. Basal fluid replacement is provided with 5 mL/kg/hr of Lactated Ringer's solution.
Cukurova University
Adana, Saricam, Turkey (Türkiye)
Change in PaO2/FiO2 Ratio During One-Lung Ventilation
Measurement of PaO2/FiO2 ratio at five time points intraoperatively to assess pulmonary oxygenation.
Time frame: Intraoperative period (from anesthesia induction to extubation).
Postoperative Pulmonary Complications
Incidence of pulmonary complications (e.g., pulmonary edema, atelectasis, acute lung injury) assessed using chest X-ray and clinical evaluation.
Time frame: Up to postoperative day 5.
Postoperative Cardiac Complications
Incidence of cardiac complications (e.g., hypotension, hypertension, dysrhythmia).
Time frame: Up to postoperative day 5.
Postoperative Renal Complications
Incidence of acute kidney injury (AKI).
Time frame: Up to postoperative day 5.
Postoperative Infectious Complications
Incidence of infections (e.g., pneumonia, surgical site infection).
Time frame: Up to postoperative day 5.
Quality of Recovery (QoR-15 Score)
Patient-reported recovery quality assessed using the QoR-15 scale.
Time frame: Postoperative 24th hour.
Length of Hospital Stay
Duration of hospital stay in days.
Time frame: From date of surgery until the date of discharge.
30-Day Hospital Readmission Rate
Rate of hospital readmissions within 30 days post-surgery.
Time frame: From date of discharge until the postoperative 30th day.
Mortality Rate
Incidence of mortality within 30 days post-surgery.
Time frame: Postoperative 30th day.
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