Goal-Directed Fluid Therapy for Thoracoscopic Lobectomy

Not Applicable

Completed

• Conditions: Thoracic Anesthesia; Lung Cancer; Enhanced Recovery After Anesthesia; Thoracoscopic Lobectomy

• Registration Number: NCT07050979
• Lead Sponsor: Cukurova University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Primary Completion: 2024-12-20
• Study Completion: 2025-01-25
• Study First Submitted: 2025-06-23
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in PaO2/FiO2 Ratio During One-Lung Ventilation	Intraoperative period (from anesthesia induction to extubation).	Measurement of PaO2/FiO2 ratio at five time points intraoperatively to assess pulmonary oxygenation.

Secondary Outcome Measures

Name	Time	Method
Postoperative Renal Complications	Up to postoperative day 5.	Incidence of acute kidney injury (AKI).
Quality of Recovery (QoR-15 Score)	Postoperative 24th hour.	Patient-reported recovery quality assessed using the QoR-15 scale.
Postoperative Pulmonary Complications	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.
Postoperative Cardiac Complications	Up to postoperative day 5.	Incidence of cardiac complications (e.g., hypotension, hypertension, dysrhythmia).
Postoperative Infectious Complications	Up to postoperative day 5.	Incidence of infections (e.g., pneumonia, surgical site infection).
Length of Hospital Stay	From date of surgery until the date of discharge.	Duration of hospital stay in days.
30-Day Hospital Readmission Rate	From date of discharge until the postoperative 30th day.	Rate of hospital readmissions within 30 days post-surgery.
Mortality Rate	Postoperative 30th day.	Incidence of mortality within 30 days post-surgery.

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Saricam, Turkey