Lung CancerNCT06855966
Feasibility of ETCO₂ Changes During Passive Leg Raise for Fluid Management in Lung Surgery
A study testing 250 ml crystalloid bolus infusion in people with Lung Cancer, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Aim: End tidal carbondioxide pressure (EtCO2) is an indirect indicator of cardiac output (CO) which is monitored in every patient at perioperative setting. The investigators aimed to use increase of EtCO2 as a response to passive leg raising maneuver (PLR) to indicate fluid responsiveness in patients who underwent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 250 ml crystalloid bolus infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2020to 15 Mar 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lung resection surgery via VATS
- ASA I-II-III
- Patients older than 18 years
Who cannot join
- ASA IV or more
- Post operative ICU stay
- Resections greater than lobectomy
- History of renal and heart failure
- Patients younger than 18 years.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa Medical School Hospital
Istanbul, Istanbul, 34098
About this study
Official title: Assessment of End-Tidal Carbon Dioxide Changes in Response to Passive Leg Raise for Guiding Fluid Management in Lung Resections: a Randomized Controlled Trial
Aim: End tidal carbondioxide pressure (EtCO2) is an indirect indicator of cardiac output (CO) which is monitored in every patient at perioperative setting. The investigators aimed to use increase of EtCO2 as a response to passive leg raising maneuver (PLR) to indicate fluid responsiveness in patients who underwent lung resection with video-assisted thoracoscopic surgery (VATS).
Read the detailed description
Materials and Methods: 50 patients included who are eligible according to inclusion criteria of the study who underwent lung resection operation via VATS between Agust 2020-March 2021. After a standardized anesthesia induction protocol and intubation, PLR is applied to all patients as soon as anesthesia depth and ventilation stabilized. An increase of 2 mmHg at EtCO2 at first minute of PLR evaluated as "fluid responsive" due to an increase of venous return. Responsive patients divided into two groups as "study" and "control" when unresponsive patiens inclueded into "unresponsive" group. Patients at study group received a fluid bolus (250 ml (and an additional 250 ml if mean arterial pressure remained below 65 mmHg )) in addition to maintainence fluid as control group and unresponsive group received only maintainence fluid. Hemodynamic data, surgery duration, total iv fluid administration, use of blood products, bleeding and urine output during surgery of all patients recorded. Preopretive and postoperative urea, creatinine and lactate levels of all patiens compared. Total iv fluid administration and urine output recorded during postoperative 24 hours.
- Conditions
- Lung Cancer
- Being tested
- 250 ml crystalloid bolus infusion
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250 ml crystalloid bolus infusionOther
In thoracic surgical setting, restrictive fluid replacement is widely accepted. However, goal directed fluid therapies can provide a more precise and tailored fluid replacement for each patient. Although ERAS protocols emphasize otherwise, patients still arrive in the operating room with certain deficite, due to prolonged fasting or advanced age. PLR is used as a reversible fluid challenge since the blood which is pooled in the lower extremities as well as splancnic area. End tidal carbon dioxide is monitorized at each patient per American Society of Anesthesia Guideline. In this study, we aimed to assess the feasibility of end tidal carbondioxide changes as a response to passive leg raise maneuer (PLR) for preload optimization in thoracic surgical practice.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | PLR applied to this group as well as other two groups. An increase of 2mmHg detected in these patients. However, this group received the conventional fluid replacement regimen of the institution of the investigators, which is 2ml/kg/hr crystalloid infusion. The blood pressure is monitorized continually in each patient from a radial artery cannula, and an infusion of noradrenaline started if mean arterial pressure persisted below 65 mmHg.The blood product replacement plan is keeping the hemoglobin level over 10 g/dL for patients with coronary artery disease and 8 g/dL for other patients. |
| Study | Experimental | PLR applied to this group as well as other two groups. A 2 mmHg increase at EtCO2 detected at 1st minute of PLR. The patients in this group named as study group and received a 250 ml of crystalloid bolus. These patients also received another 250 ml crystalloid bolus if mean arterial pressure is below 65 mmHg at the end of infusion.The blood pressure is monitorized continually in each patient from a radial artery cannula, and an infusion of noradrenaline started if mean arterial pressure persisted below 65 mmHg after total of 500 ml crystalloid bolus.The blood product replacement plan is keeping the hemoglobin level over 10 g/dL for patients with coronary artery disease and 8 g/dL for other patients. Receives: Other: 250 ml crystalloid bolus infusion |
| Unresponsive | No intervention | Patients in this group showed no change at End tidal carbon dioxide measurement as a response to PLR and received the conventional fluid replacement regimen of the institution of the investigators, which is 2ml/kg/hr crystalloid infusion.The blood pressure is monitorized continually in each patient from a radial artery cannula, and an infusion of noradrenaline started if mean arterial pressure persisted below 65 mmHg.The blood product replacement plan is keeping the hemoglobin level over 10 g/dL for patients with coronary artery disease and 8 g/dL for other patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in End-Tidal Carbon Dioxide (EtCO₂) in Response to Passive Leg Raise (PLR)
Measurement Method: EtCO₂ (mmHg) will be recorded using a side-stream capnograph integrated into the anesthesia workstation. Baseline EtCO₂ will be measured in the supine position before the PLR maneuver. The PLR maneuver will then be performed by elevating the lower extremities to a 45-degree angle while maintaining a supine upper body position. The position remained for 1 minute and the maximum level of EtCO₂recorded.
Outcome Definition: A ≥2 mmHg increase in EtCO₂ from baseline within 1 minute of PLR will be classified as a positive response, indicating fluid responsiveness. Patients with an EtCO₂ increase of <2 mmHg will be classified as non-responders.
Measured: Time Frame: Intraoperative (Baseline and 1 Minute After PLR)
Secondary outcomes (3)
Change in Serum Urea Levels
Blood samples will be collected at baseline (preoperative), and at 24 hours postoperatively for all participants. If the patient remains hospitalized at 48 hours, an additional blood sample for urea will be collected. Serum urea (mg/dL) levels will be analyzed using standard laboratory biochemical methods.
Measured: Preoperative, 24 hours, and 48 hours postoperatively (if patient remains hospitalized)
Change in Serum Creatinine Levels
Blood samples will be collected at baseline (preoperative), and at 24 hours postoperatively for all participants. If the patient remains hospitalized at 48 hours, an additional blood sample for creatinine will be collected. Serum creatinine (mg/dL) levels will be analyzed using standard laboratory biochemical methods.
Measured: Preoperative, 24 hours, and 48 hours postoperatively (if patient remains hospitalized)
Change in Serum Lactate Levels
Blood samples will be collected at baseline (preoperative), and at 24 hours postoperatively for all participants. Serum lactate (mmol/L) levels will be analyzed using standard laboratory biochemical methods.
Measured: Preoperative, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start4 Aug 2020
- Primary completion14 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Suheyla Akin Uzan, Istanbul University - Cerrahpasa
- Investigators
- Lale Yuceyar, Professor, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855966
- Sponsor's protocol ID
- IstanbulUC-AR-HSAU-01
- Status last verified
- Mar 2025
- First submitted
- 5 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Uzan HSA, Yuceyar L, Sayilgan NC. End-tidal CO2 response to passive leg raise for fluid management in lung resections: A randomized controlled trial. Pak J Med Sci. 2025 Dec;41(12):3393-3398. doi: 10.12669/pjms.41.12.12679.
PubMed 41450995
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of End-Tidal Carbon Dioxide Changes in Response to Passive Leg Raise for Guiding Fluid Management in Lung Resections: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06855966
- Acronym / sponsor ID
- IstanbulUC-AR-HSAU-01
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 14 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 4 Mar 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.
Aim: End tidal carbondioxide pressure (EtCO2) is an indirect indicator of cardiac output (CO) which is monitored in every patient at perioperative setting. The investigators aimed to use increase of EtCO2 as a response to passive leg raising maneuver (PLR) to indicate fluid responsiveness in patients who underwent lung resection with video-assisted thoracoscopic surgery (VATS).
Detailed description
Materials and Methods: 50 patients included who are eligible according to inclusion criteria of the study who underwent lung resection operation via VATS between Agust 2020-March 2021. After a standardized anesthesia induction protocol and intubation, PLR is applied to all patients as soon as anesthesia depth and ventilation stabilized. An increase of 2 mmHg at EtCO2 at first minute of PLR evaluated as "fluid responsive" due to an increase of venous return. Responsive patients divided into two groups as "study" and "control" when unresponsive patiens inclueded into "unresponsive" group. Patients at study group received a fluid bolus (250 ml (and an additional 250 ml if mean arterial pressure remained below 65 mmHg )) in addition to maintainence fluid as control group and unresponsive group received only maintainence fluid. Hemodynamic data, surgery duration, total iv fluid administration, use of blood products, bleeding and urine output during surgery of all patients recorded. Preopretive and postoperative urea, creatinine and lactate levels of all patiens compared. Total iv fluid administration and urine output recorded during postoperative 24 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –PLR applied to this group as well as other two groups. An increase of 2mmHg detected in these patients. However, this group received the conventional fluid replacement regimen of the institution of the investigators, which is 2ml/kg/hr crystalloid infusion. The blood pressure is monitorized continually in each patient from a radial artery cannula, and an infusion of noradrenaline started if mean arterial pressure persisted below 65 mmHg.The blood product replacement plan is keeping the hemoglobin level over 10 g/dL for patients with coronary artery disease and 8 g/dL for other patients. |
| Study | Experimental | Other: 250 ml crystalloid bolus infusionPLR applied to this group as well as other two groups. A 2 mmHg increase at EtCO2 detected at 1st minute of PLR. The patients in this group named as study group and received a 250 ml of crystalloid bolus. These patients also received another 250 ml crystalloid bolus if mean arterial pressure is below 65 mmHg at the end of infusion.The blood pressure is monitorized continually in each patient from a radial artery cannula, and an infusion of noradrenaline started if mean arterial pressure persisted below 65 mmHg after total of 500 ml crystalloid bolus.The blood product replacement plan is keeping the hemoglobin level over 10 g/dL for patients with coronary artery disease and 8 g/dL for other patients. |
| Unresponsive | No intervention | –Patients in this group showed no change at End tidal carbon dioxide measurement as a response to PLR and received the conventional fluid replacement regimen of the institution of the investigators, which is 2ml/kg/hr crystalloid infusion.The blood pressure is monitorized continually in each patient from a radial artery cannula, and an infusion of noradrenaline started if mean arterial pressure persisted below 65 mmHg.The blood product replacement plan is keeping the hemoglobin level over 10 g/dL for patients with coronary artery disease and 8 g/dL for other patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing lung resection surgery via VATS
- ASA I-II-III
- Patients older than 18 years
Key exclusion criteria (5 listed)
- ASA IV or more
- Post operative ICU stay
- Resections greater than lobectomy
- History of renal and heart failure
- Patients younger than 18 years.
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 |
|---|---|---|
| 250 ml crystalloid bolus infusionIn thoracic surgical setting, restrictive fluid replacement is widely accepted. However, goal directed fluid therapies can provide a more precise and tailored fluid replacement for each patient. Although ERAS protocols emphasize otherwise, patients still arrive in the operating room with certain deficite, due to prolonged fasting or advanced age. PLR is used as a reversible fluid challenge since the blood which is pooled in the lower extremities as well as splancnic area. End tidal carbon dioxide is monitorized at each patient per American Society of Anesthesia Guideline. In this study, we aimed to assess the feasibility of end tidal carbondioxide changes as a response to passive leg raise maneuer (PLR) for preload optimization in thoracic surgical practice. | Other | Study |
Primary outcome
Change in End-Tidal Carbon Dioxide (EtCO₂) in Response to Passive Leg Raise (PLR)
Time frame: Time Frame: Intraoperative (Baseline and 1 Minute After PLR)
Measurement Method: EtCO₂ (mmHg) will be recorded using a side-stream capnograph integrated into the anesthesia workstation. Baseline EtCO₂ will be measured in the supine position before the PLR maneuver. The PLR maneuver will then be performed by elevating the lower extremities to a 45-degree angle while maintaining a supine upper body position. The position remained for 1 minute and the maximum level of EtCO₂recorded. Outcome Definition: A ≥2 mmHg increase in EtCO₂ from baseline within 1 minute of PLR will be classified as a positive response, indicating fluid responsiveness. Patients with an EtCO₂ increase of <2 mmHg will be classified as non-responders.
3 secondary outcomes
Change in Serum Urea Levels
Time frame: Preoperative, 24 hours, and 48 hours postoperatively (if patient remains hospitalized)
Change in Serum Creatinine Levels
Time frame: Preoperative, 24 hours, and 48 hours postoperatively (if patient remains hospitalized)
Change in Serum Lactate Levels
Time frame: Preoperative, 24 hours
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 4 Mar 2025.
- Derived from this study: PubMed 41450995Uzan HSA, Yuceyar L, Sayilgan NC. End-tidal CO2 response to passive leg raise for fluid management in lung resections: A randomized controlled trial. Pak J Med Sci. 2025 Dec;41(12):3393-3398. doi: 10.12669/pjms.41.12.12679.
- Individual participant dataSharing planned: No
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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.
Lale Yuceyar, Professor study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 250 ml crystalloid bolus infusion in people with Lung Cancer, run by Istanbul University - Cerrahpasa 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 3 inclusion and 5 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 4 Mar 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 End-Tidal Carbon Dioxide (EtCO₂) in Response to Passive Leg Raise (PLR) (time frame: Time Frame: Intraoperative (Baseline and 1 Minute After PLR)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06855966, which also lists 1 linked publication.
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 4 Mar 2025.