Thoracoscopic LobectomyNCT07050979
Goal-Directed Fluid Therapy for Thoracoscopic Lobectomy
A study testing Goal-Directed Fluid Therapy (GDFT) and Conventional Fluid Therapy in people with Thoracoscopic Lobectomy and Thoracic Anesthesia, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracoscopic Lobectomy, Thoracic Anesthesia, Enhanced Recovery After Anesthesia
- What is being tested?
- Goal-Directed Fluid Therapy (GDFT) and Conventional Fluid Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 25 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- ASA Physical Status Classification I-II.
- Undergoing elective thoracoscopic lobectomy with the ERAS protocol.
- Provided informed consent.
Who cannot join
- 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)
Show all 9Show fewer
- Patients who cannot be applied to the ERAS protocol
- Emergency surgery.
- Refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Goal-Directed Fluid Therapy Versus Conventional Fluid Therapy for Thoracoscopic Lobectomy in the ERAS Era: A Randomized Controlled Trial
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
- Being tested
- Goal-Directed Fluid Therapy (GDFT), Conventional Fluid Therapy
- Keywords
- Goal directed fluid therapy, Enhanced Recovery After Anesthesia, Pressure Recording Analytical Method, Stroke volume variation, Cardiac index
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Fluid Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PaO2/FiO2 Ratio During One-Lung Ventilation
Measurement of PaO2/FiO2 ratio at five time points intraoperatively to assess pulmonary oxygenation.
Measured: Intraoperative period (from anesthesia induction to extubation).
Secondary outcomes (8)
Postoperative Pulmonary Complications
Incidence of pulmonary complications (e.g., pulmonary edema, atelectasis, acute lung injury) assessed using chest X-ray and clinical evaluation.
Measured: Up to postoperative day 5.
Postoperative Cardiac Complications
Incidence of cardiac complications (e.g., hypotension, hypertension, dysrhythmia).
Measured: Up to postoperative day 5.
Postoperative Renal Complications
Incidence of acute kidney injury (AKI).
Measured: Up to postoperative day 5.
Postoperative Infectious Complications
Incidence of infections (e.g., pneumonia, surgical site infection).
Measured: Up to postoperative day 5.
Quality of Recovery (QoR-15 Score)
Patient-reported recovery quality assessed using the QoR-15 scale.
Measured: Postoperative 24th hour.
Length of Hospital Stay
Duration of hospital stay in days.
Measured: From date of surgery until the date of discharge.
30-Day Hospital Readmission Rate
Rate of hospital readmissions within 30 days post-surgery.
Measured: From date of discharge until the postoperative 30th day.
Mortality Rate
Incidence of mortality within 30 days post-surgery.
Measured: Postoperative 30th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start1 Jun 2024
- Primary completion20 Dec 2024
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoscopic LobectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Laflı Tunay, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07050979
- Sponsor's protocol ID
- GDFTinERAS
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-Directed Fluid Therapy Versus Conventional Fluid Therapy for Thoracoscopic Lobectomy in the ERAS Era: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07050979
- Acronym / sponsor ID
- GDFTinERAS
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Goal-Directed Fluid Therapy (GDFT) | Experimental | Other: 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. |
| Conventional Fluid Therapy | Active comparator | Other: Conventional Fluid TherapyPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years.
- ASA Physical Status Classification I-II.
- Undergoing elective thoracoscopic lobectomy with the ERAS protocol.
- Provided informed consent.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-Directed Fluid Therapy (GDFT)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. | Other | Goal-Directed Fluid Therapy (GDFT) |
| Conventional Fluid TherapyThis 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. | Other | Conventional Fluid Therapy |
Primary outcome
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.
8 secondary outcomes
Postoperative Pulmonary Complications
Time frame: Up to postoperative day 5.
Postoperative Cardiac Complications
Time frame: Up to postoperative day 5.
Postoperative Renal Complications
Time frame: Up to postoperative day 5.
Postoperative Infectious Complications
Time frame: Up to postoperative day 5.
Quality of Recovery (QoR-15 Score)
Time frame: Postoperative 24th hour.
Length of Hospital Stay
Time frame: From date of surgery until the date of discharge.
30-Day Hospital Readmission Rate
Time frame: From date of discharge until the postoperative 30th day.
Mortality Rate
Time frame: Postoperative 30th day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Directed Fluid Therapy (GDFT) and Conventional Fluid Therapy in people with Thoracoscopic Lobectomy and Thoracic Anesthesia, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PaO2/FiO2 Ratio During One-Lung Ventilation (time frame: Intraoperative period (from anesthesia induction to extubation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.