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Completed

NCT Number: NCT06855966

Feasibility of ETCO₂ Changes During Passive Leg Raise for Fluid Management in Lung Surgery

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).

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa Medical School Hospital

Istanbul, 34098, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing lung resection surgery via VATS
  • ASA I-II-III
  • Patients older than 18 years

Exclusion criteria

  • ASA IV or more
  • Post operative ICU stay
  • Resections greater than lobectomy
  • History of renal and heart failure
  • Patients younger than 18 years.

Treatment and study plan

250 ml crystalloid bolus infusion

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Serum Urea Levels

    Time frame: Preoperative, 24 hours, and 48 hours postoperatively (if patient remains hospitalized)

    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.

  2. Change in Serum Creatinine Levels

    Time frame: Preoperative, 24 hours, and 48 hours postoperatively (if patient remains hospitalized)

    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.

  3. Change in Serum Lactate Levels

    Time frame: Preoperative, 24 hours

    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.

Other outcomes

  1. Correlation Between Pleth Variability Index (PVI) and Fluid Responsiveness Based on EtCO₂ Changes

    Time frame: Time Frame: Intraoperative (Baseline and during 1 Minute of PLR maneuer)

    PVI (%) will be recorded before and after PLR using Masimo Rainbow SET. Correlation between PVI values and EtCO₂-based fluid responsiveness classification (≥2 mmHg EtCO₂ increase) will be analyzed.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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