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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pulmonary Complications | Incidence of pulmonary complications (e.g., pulmonary edema, atelectasis, acute lung injury) assessed using chest X-ray and clinical evaluation. | Up to postoperative day 5. |
| Postoperative Cardiac Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cukurova University | Adana | Saricam | 01330 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
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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.
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| 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. |
|
Incidence of cardiac complications (e.g., hypotension, hypertension, dysrhythmia).
| Up to postoperative day 5. |
| Postoperative Renal Complications | Incidence of acute kidney injury (AKI). | Up to postoperative day 5. |
| Postoperative Infectious Complications | Incidence of infections (e.g., pneumonia, surgical site infection). | Up to postoperative day 5. |
| Quality of Recovery (QoR-15 Score) | Patient-reported recovery quality assessed using the QoR-15 scale. | Postoperative 24th hour. |
| Length of Hospital Stay | Duration of hospital stay in days. | From date of surgery until the date of discharge. |
| 30-Day Hospital Readmission Rate | Rate of hospital readmissions within 30 days post-surgery. | From date of discharge until the postoperative 30th day. |
| Mortality Rate | Incidence of mortality within 30 days post-surgery. | Postoperative 30th day. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |