Feasibility of ETCO₂ Changes During Passive Leg Raise for Fluid Management in Lung Surgery
Assessment of End-Tidal Carbon Dioxide Changes in Response to Passive Leg Raise for Guiding Fluid Management in Lung Resections: a Randomized Controlled Trial
1 other identifier
interventional
53
1 country
1
Brief 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 lung resection with video-assisted thoracoscopic surgery (VATS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable lung-cancer
Started Aug 2020
Shorter than P25 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2021
CompletedFirst Submitted
Initial submission to the registry
February 5, 2025
CompletedFirst Posted
Study publicly available on registry
March 4, 2025
CompletedMarch 4, 2025
March 1, 2025
7 months
February 5, 2025
March 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Time Frame: Intraoperative (Baseline and 1 Minute After PLR)
Secondary Outcomes (3)
Change in Serum Urea Levels
Preoperative, 24 hours, and 48 hours postoperatively (if patient remains hospitalized)
Change in Serum Creatinine Levels
Preoperative, 24 hours, and 48 hours postoperatively (if patient remains hospitalized)
Change in Serum Lactate Levels
Preoperative, 24 hours
Other Outcomes (1)
Correlation Between Pleth Variability Index (PVI) and Fluid Responsiveness Based on EtCO₂ Changes
Time Frame: Intraoperative (Baseline and during 1 Minute of PLR maneuer)
Study Arms (3)
Control
NO INTERVENTIONPLR 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
EXPERIMENTALPLR 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 INTERVENTIONPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients undergoing lung resection surgery via VATS
- ASA I-II-III
- Patients older than 18 years
You may not qualify if:
- ASA IV or more
- Post operative ICU stay
- Resections greater than lobectomy
- History of renal and heart failure
- Patients younger than 18 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University-Cerrahpasa Medical School Hospital
Istanbul, Istanbul, 34098, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 41450995DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lale Yuceyar, Professor
Istanbul University - Cerrahpasa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
February 5, 2025
First Posted
March 4, 2025
Study Start
August 4, 2020
Primary Completion
March 14, 2021
Study Completion
March 15, 2021
Last Updated
March 4, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share