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

NCT ID: NCT06855966

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-04
• Study Completion Date: 2021-03-15

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study

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.

Group Type: EXPERIMENTAL

250 ml crystalloid bolus infusion

Intervention Type: 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.

Unresponsive

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

250 ml crystalloid bolus infusion

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Havva Suheyla Akin Uzan

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lale Yuceyar, Professor

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa Medical School Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IstanbulUC-AR-HSAU-01

Identifier Type: -

Identifier Source: org_study_id