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NCT Number: NCT07050979

Goal-Directed Fluid Therapy for Thoracoscopic Lobectomy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, Saricam, 01330, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Postoperative Pulmonary Complications

    Time frame: 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.

  2. Postoperative Cardiac Complications

    Time frame: Up to postoperative day 5.

    Incidence of cardiac complications (e.g., hypotension, hypertension, dysrhythmia).

  3. Postoperative Renal Complications

    Time frame: Up to postoperative day 5.

    Incidence of acute kidney injury (AKI).

  4. Postoperative Infectious Complications

    Time frame: Up to postoperative day 5.

    Incidence of infections (e.g., pneumonia, surgical site infection).

  5. Quality of Recovery (QoR-15 Score)

    Time frame: Postoperative 24th hour.

    Patient-reported recovery quality assessed using the QoR-15 scale.

  6. Length of Hospital Stay

    Time frame: From date of surgery until the date of discharge.

    Duration of hospital stay in days.

  7. 30-Day Hospital Readmission Rate

    Time frame: From date of discharge until the postoperative 30th day.

    Rate of hospital readmissions within 30 days post-surgery.

  8. Mortality Rate

    Time frame: Postoperative 30th day.

    Incidence of mortality within 30 days post-surgery.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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