Cukurova University
Adana, Saricam, 01330, Turkey (Türkiye)
NCT Number: NCT07050979
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Adana, Saricam, 01330, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Intraoperative period (from anesthesia induction to extubation).
Measurement of PaO2/FiO2 ratio at five time points intraoperatively to assess pulmonary oxygenation.
Time frame: Up to postoperative day 5.
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.
Incidence of cardiac complications (e.g., hypotension, hypertension, dysrhythmia).
Time frame: Up to postoperative day 5.
Incidence of acute kidney injury (AKI).
Time frame: Up to postoperative day 5.
Incidence of infections (e.g., pneumonia, surgical site infection).
Time frame: Postoperative 24th hour.
Patient-reported recovery quality assessed using the QoR-15 scale.
Time frame: From date of surgery until the date of discharge.
Duration of hospital stay in days.
Time frame: From date of discharge until the postoperative 30th day.
Rate of hospital readmissions within 30 days post-surgery.
Time frame: Postoperative 30th day.
Incidence of mortality within 30 days post-surgery.
Cukurova University
Other
Goal-Directed Fluid Therapy Versus Conventional Fluid Therapy for Thoracoscopic Lobectomy in the ERAS Era: A Randomized Controlled Trial
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