NCT07050979

Goal-Directed Fluid Therapy for Thoracoscopic Lobectomy

Goal-Directed Fluid Therapy Versus Conventional Fluid Therapy for Thoracoscopic Lobectomy in the ERAS Era: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Cukurova University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Thoracoscopic Lobectomy
• Thoracic Anesthesia
• Enhanced Recovery After Anesthesia
• Lung Cancer

Interventions

Type	Name	Description
OTHER	Goal-Directed Fluid Therapy (GDFT)	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.
OTHER	Conventional Fluid Therapy	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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-12-20
• Completion: 2025-01-25
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: Turkey (Türkiye)