Goal-Directed Fluid Therapy for Thoracoscopic Lobectomy

NCT07050979 | Completed

• 1 other identifier: GDFTinERAS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Goal directed fluid therapy; Enhanced Recovery After Anesthesia; Pressure Recording Analytical Method; Stroke volume variation; Cardiac index

Outcome Measures

Primary Outcomes (1)

• Change in PaO2/FiO2 Ratio During One-Lung Ventilation

  Measurement of PaO2/FiO2 ratio at five time points intraoperatively to assess pulmonary oxygenation.

  Intraoperative period (from anesthesia induction to extubation).

Secondary Outcomes (8)

• Postoperative Pulmonary Complications

  Up to postoperative day 5.

• Postoperative Cardiac Complications

  Up to postoperative day 5.

• Postoperative Renal Complications

  Up to postoperative day 5.

• Postoperative Infectious Complications

  Up to postoperative day 5.

• Quality of Recovery (QoR-15 Score)

  Postoperative 24th hour.

Study Arms (2)

Goal-Directed Fluid Therapy (GDFT)

EXPERIMENTAL

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.

Other: Goal-Directed Fluid Therapy (GDFT)

Conventional Fluid Therapy

ACTIVE COMPARATOR

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.

Other: Conventional Fluid Therapy

Interventions

Goal-Directed Fluid Therapy (GDFT) 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.

Goal-Directed Fluid Therapy (GDFT)

Conventional Fluid Therapy 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.

Conventional Fluid Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Saricam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients meeting the inclusion criteria were randomized into the intervention (goal directed fluid therapy - group GDFT, n=40) or control (conventional fluid therapy - control group, n=40) groups using opaque sealed envelopes.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 3, 2025
• Study Start: June 1, 2024
• Primary Completion: December 20, 2024
• Study Completion: January 25, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

TU (1)