Trending Ability of End-Tidal Capnography to Reflect Arterial Carbon Dioxide Changes in One-Lung Ventilation

Do End-Tidal Capnography Trends Reflect Changes in Arterial Carbon Dioxide Partial Pressure During One-Lung Ventilation for Thoracoscopic Surgery? A Prospective Observational Study

In this study, we want to find out if measuring carbon dioxide from a patient's breath (end-tidal CO₂ or ETCO₂) can reliably reflect changes in blood carbon dioxide levels (arterial CO₂ or PaCO₂) during lung surgery. Instead of just looking at individual values, we are specifically investigating whether ETCO₂ and PaCO₂ rise and fall in the same direction over time.

During lung surgery, patients often need "one-lung ventilation," where only one lung is used for breathing while the other is deflated to help the surgeon. This can cause carbon dioxide levels in the blood to change, which are typically monitored by taking blood samples. If ETCO₂ trends closely follow PaCO₂ trends, doctors may not need to take as many blood samples.

Patients in this study will already have a small tube in an artery for monitoring blood pressure. Whenever a blood test is taken, we will compare the blood CO₂ level with the ETCO₂ reading at that moment. We will also track heart rate, blood pressure, and body temperature.

By comparing these measurements, we hope to learn whether ETCO₂ reliably follows the same trends as PaCO₂, making it a useful tool for monitoring carbon dioxide levels in lung surgery with fewer blood tests.

Study Overview

• Status: Not yet recruiting
• Conditions: One-Lung Ventilation; Blood Gas Analysis; Capnography; Video-Assisted Thoracoscopic Surgery

Detailed Description

Thoracoscopic lung surgery often requires one-lung ventilation, a technique in which only one lung is ventilated while the other is deflated to provide better access for the surgeon. This can lead to changes in blood carbon dioxide (PaCO₂) levels, which must be monitored closely to ensure patient safety. Arterial blood gas sampling remains the gold standard for measuring PaCO₂, but it is invasive, costly, and provides only intermittent data. End-tidal carbon dioxide (ETCO₂) monitoring, available through standard anesthesia devices, offers continuous, noninvasive measurement of exhaled CO₂ and can serve as a surrogate for PaCO₂.

The primary purpose of this study is to evaluate the agreement and trend correlation between ETCO₂ and PaCO₂ in patients undergoing thoracoscopic procedures with one-lung ventilation. If ETCO₂ reliably tracks changes in PaCO₂, clinicians may reduce the number of arterial blood gas samples required during these operations.

Primary objective: To evaluate the trend correlation between ETCO₂ and PaCO₂ over time.

Secondary objective: To determine the degree of agreement between ETCO₂ and PaCO₂

Study Type: Prospective, observational study. Study Setting: Operating rooms where adult patients (≥18 years old) are scheduled for thoracoscopic procedures with one-lung ventilation and require invasive arterial pressure monitoring as part of their routine care.

Duration: Each patient's participation will be limited to the intraoperative period (i.e., from anesthesia induction to the end of surgery).

Intraoperative management will follow a standardized anesthetic protocol, and arterial blood gas samples will be drawn at the anesthesiologist's discretion whenever clinically indicated.

Each time an arterial blood gas sample is taken, the corresponding ETCO₂, PaCO₂, arterial blood pressure, heart rate, and temperature values will be recorded.

Any use of inotropic or antihypertensive infusions will be documented, as such medications can influence hemodynamic stability and possibly ventilatory parameters.

The patient's demographic details (age, sex, height, weight) and the type of surgical procedure will be recorded.

Four-quadrant plots will be generated to assess the concordance of changes in ETCO₂ with changes in PaCO₂ over time.

Bland-Altman plots will be constructed to calculate the mean difference (bias) and 95% limits of agreement for each paired measurement.

• Study Type: Observational
• Enrollment (Estimated): 115

Contacts and Locations

• Study Contact: Name: Muhammet S Söğüt, Anesthesiologist; Phone Number: 00905056183219; Email: selmansogut@gmail.com
• Study Contact Backup: Name: Kamil Darçın, Anesthesiologist; Phone Number: 00905055895099; Email: kdarcin@kuh.ku.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants will be drawn from the adult patient population (≥18 years) scheduled for thoracoscopic lung surgery with one-lung ventilation at a tertiary care hospital. These individuals are already indicated to receive invasive arterial blood pressure monitoring as part of their routine clinical management. No special outreach or community recruitment methods will be employed; rather, eligible patients will be identified from the hospital's surgical wards and preoperative clinics.

Description

Inclusion Criteria:

• Patients undergoing thoracoscopic lung surgery with one-lung ventilation
• Patients requiring invasive arterial blood pressure monitoring

Exclusion Criteria:

• Chronic obstructive pulmonary disease (COPD)
• Pulmonary hypertension
• Systemic infection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trend correlation between ETCO₂ and PaCO₂ measured by the concordance ratio in the four-quadrant plot	A four-quadrant plot will be generated by comparing consecutive changes (deltas) in PaCO₂ and ETCO₂. For each patient, every pair of sequential measurements will be used to calculate ΔPaCO₂ (horizontal axis) and ΔETCO₂ (vertical axis). Points in the top-right (Quadrant I) and bottom-left (Quadrant III) indicate concordant changes (both variables increased or both decreased). A "central zone" will be defined to exclude clinically negligible fluctuations (±1mmHg). The percentage of points in Quadrant I and III, relative to those outside the central zone, will be reported as the overall concordance. A concordance ratio above 90% will be considered as good trending ability.	During the surgery of the patient, arterial blood gas samples will be drawn at the anesthesiologist's discretion whenever clinically indicated.
Trend correlation between ETCO₂ and PaCO₂ measured by the angular bias in the four-quadrant plot	In the four-quadrant plot, the angle of each data point relative to the 45-degree line will be calculated. The average of this angles will be reported as angular bias. An angular bias between ±5 degrees will be considered as good trending ability.	During the surgery of the patient, arterial blood gas samples will be drawn at the anesthesiologist's discretion whenever clinically indicated.
Trend correlation between ETCO₂ and PaCO₂ measured by radial limits of aggreement in the four-quadrant plot	In the four-quadrant plot, the angle of each data point relative to the 45-degree line will be calculated. The radial sector relative to the 45-degree line that contains 95% of the data points will be reported as radial limits of agreement. Radial limits of agreement between ±30 degrees will be considered as good trending ability.	During the surgery of the patient, arterial blood gas samples will be drawn at the anesthesiologist's discretion whenever clinically indicated.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aggreement between simultaneous ETCO₂ and PaCO₂ values measured by limits of aggreement in Bland-Altman plot	A Bland-Altman plot will be used to assess agreement between ETCO₂ and PaCO₂. For each paired measurement, the difference between ETCO₂ and PaCO₂, and the average of ETCO₂ and PaCO₂ will be calculated. Each point will be plotted with the difference on the vertical axis against the average on the horizontal axis. The mean difference (bias) and 95% limits of agreement (mean difference ± 1.96 × Standard deviation of the difference) will then be calculated. Limits of aggreement between ±4 mmHg will be considered as good aggreement.	During the surgery of the patient, arterial blood gas samples will be drawn at the anesthesiologist's discretion whenever clinically indicated.

Collaborators and Investigators

• Sponsor: Koç University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 10, 2025

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024.269.IRB1.033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No