Goal-Directed Fluid Therapy for Thoracoscopic Lobectomy

NCT ID: NCT07050979

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-01-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Goal-Directed Fluid Therapy (GDFT)

Patients receive intraoperative fluid and vasopressor therapy guided by Stroke Volume Variation (SVV \< 15%) and Cardiac Index (CI \> 2.6 L/min/m²) using the Pressure Recording Analytical Method (PRAM). Basal fluid replacement is provided with 5 mL/kg/hour Lactated Ringer's solution.

Group Type: EXPERIMENTAL

Goal-Directed Fluid Therapy (GDFT)

Intervention Type: OTHER

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.

Conventional Fluid Therapy

Patients receive intraoperative fluid and vasopressor therapy targeting Mean Arterial Pressure (MAP) of 65-95 mmHg and minimum hourly urine output of 0.5 mL/kg/hour. Basal fluid replacement is provided with 5 mL/kg/hour Lactated Ringer's solution.

Group Type: ACTIVE_COMPARATOR

Conventional Fluid Therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18-65 years.
• ASA Physical Status Classification I-II.
• Undergoing elective thoracoscopic lobectomy with the ERAS protocol.
• Provided informed consent.

Exclusion Criteria

• Age < 18 or > 65 years.
• ASA Physical Status Classification III or higher.
• Patients not in sinus rhythm, and with recent oral beta-blocker use.
• Patients with cardiac/renal/hepatic insufficiency, valvular heart disease (aortic or mitral valve insufficiency or stenosis)
• Patients with abnormal preoperative lung function (forced expiratory volume in 1 second less than 50% of predicted values)
• Patients with severe obesity (BMI>35 kg/m2)
• Patients who cannot be applied to the ERAS protocol
• Emergency surgery.
• Refusal to provide informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

Demet Laflı Tunay

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cukurova University

Adana, Saricam, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GDFTinERAS

Identifier Type: -

Identifier Source: org_study_id