NCT06855966

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Aug 2020

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 4, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

February 5, 2025

Last Update Submit

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 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.

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.

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.

Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lale Yuceyar, Professor

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

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

Locations