NCT07050979Completed
Goal-Directed Fluid Therapy for Thoracoscopic Lobectomy
Goal-Directed Fluid Therapy Versus Conventional Fluid Therapy for Thoracoscopic Lobectomy in the ERAS Era: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 23 Jun 2025
- Start date
- 1 Jun 2024
- Primary completion date
- 20 Dec 2024
- Lead sponsor
- Cukurova University
- Diseases
- Stroke, Lung cancer
- NCT number
- NCT07050979
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 1 Jun 2024 to the primary completion date, 20 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency surgery.
Other illness
- Patients with cardiac/renal/hepatic insufficiency, valvular heart disease (aortic or mitral valve insufficiency or stenosis)
Age
- Age \< 18 or \> 65 years.
Other
- ASA Physical Status Classification III or higher.
- Patients not in sinus rhythm, and with recent oral beta-blocker use.
- 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
- Refusal to provide informed consent.
Who the study is looking for
- Age 18-65 years.
- ASA Physical Status Classification I-II.
- Undergoing elective thoracoscopic lobectomy with the ERAS protocol.
- Provided informed consent.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cukurova University Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.