Goal-Directed Fluid Therapy Versus Conventional Fluid Therapy for Thoracoscopic Lobectomy in the ERAS Era: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cukurova University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in PaO2/FiO2 Ratio During One-Lung Ventilation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The anesthesiologist responsible for intraoperative management was aware of the group assignments, but other members of the research team, other healthcare providers, and patients were unaware. Confidentiality of randomization to the investigators was maintained until the end of the study for statistical data analysis.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Goal-Directed Fluid Therapy (GDFT) (Other)
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.
Intervention: Conventional Fluid Therapy (Other)
Outcomes
Primary Outcomes
Change in PaO2/FiO2 Ratio During One-Lung Ventilation
Time Frame: Intraoperative period (from anesthesia induction to extubation).
Measurement of PaO2/FiO2 ratio at five time points intraoperatively to assess pulmonary oxygenation.
Secondary Outcomes
- Mortality Rate(Postoperative 30th day.)
- Postoperative Pulmonary Complications(Up to postoperative day 5.)
- Postoperative Cardiac Complications(Up to postoperative day 5.)
- Postoperative Infectious Complications(Up to postoperative day 5.)
- Postoperative Renal Complications(Up to postoperative day 5.)
- Quality of Recovery (QoR-15 Score)(Postoperative 24th hour.)
- Length of Hospital Stay(From date of surgery until the date of discharge.)
- 30-Day Hospital Readmission Rate(From date of discharge until the postoperative 30th day.)
Investigators
Demet Laflı Tunay
Associate Professor
Cukurova University