During Chest Surgery, One Lung is Isolated from Ventilation to Improve Visibility, with Carbon Dioxide Introduced Between the Lung and Chest Wall (capnothorax): the Study Seeks to Optimize Ventilation Through Esophageal Pressure Measurement, Reducing Respiratory Complications. (CapnoPes)

February 23, 2025 updated by: Gianluigi Lauro, Cardarelli Hospital

The Use of Esophageal Pressure As a Guide to Set One Lung Ventilation During Capnothorax.

The objective of this single-center observational study is to improve the safety and effectiveness of chest surgery through the use of a new ventilation technique. During the operation, to allow the surgeon to work more precisely, only one lung will receive air from the respirator. To improve visibility during surgery, a small amount of carbon dioxide is introduced into the space between the lung and the chest wall, a procedure called capnothorax. The aim of the research is to find the best way to set the patient's ventilation during the operation, ensuring adequate oxygenation and minimizing the risks to the lung. To do this, we will use a method of measuring the pressure inside the esophagus, which will allow us to better understand the status of the lungs and adjust ventilation accordingly. Esophageal pressure is an indirect measure of the pressure within the lung. By measuring this pressure, we can get important information about the status of the lungs and their ability to expand and contract. By measuring esophageal pressure, researchers will be able to set ventilation more precisely, optimizing the amount of air that is supplied to the lungs and the pressure inside the lungs themselves. This could help prevent lung damage and improve the patient's breathing during and after surgery, reducing respiratory complications and improving patients' quality of life.

General data collected at the beginning of the study and before the surgical intervention:

  • date of birth, gender, weight, and height,
  • information and scores regarding the fitness for general anesthesia techniques,
  • anesthesia risk assessment made by the American Society of Anesthesiologists (ASA),
  • data related to respiratory mechanics.

Data collected during the surgical intervention:

  • data related to respiratory mechanics measured at the ventilator,
  • data recorded by the optivent monitor to which the esophageal probe is connected,
  • hemodynamic data collected through a semi-invasive arterial blood pressure monitoring system,
  • arterial blood gas analysis,
  • pulmonary ultrasound findings.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The aim of the study is to evaluate whether esophageal pressure can be useful in titration of adequate positive end-expiratory pressure (peep) during one-lung ventilation in robotic thoracic surgery, with repeated measurements on a single group of patients, to prevent atelectrauma, barotrauma, (VILI) ventilator-induced lung injury and post-operative pulmonary complications. The analysis will be carried out by analyzing the patients' medical records and data collection forms.

Study phase 1: screening for inclusion and informed consent, phase 2: monitoring and analysis of intraoperative data.

All patients will be subjected to general anesthesia with positioning of the double-lumen tube, with subsequent control of the correct positioning with the fiber bronchoscope. A volume-controlled ventilation mode will be set, so as to have an expiratory transpulmonary pressure (ptp exp) according to Talmor above 0 and a derived transpulmonary inspiratory pressure < 20 (according to Gattinoni) in each phase of ventilation. The Nutrivent tube is then positioned for the measurement of esophageal pressure and hemodynamic monitoring through semi-invasive blood pressure measurement. Then there is the positioning of the patient in lateral or semilateral decubitus and the OLV and after the capnothorax, the alveolar recruitment maneuver is carried out.

Measurements of ventilatory mechanics parameters and blood gas analysis will be carried out after:

  • 15 minutes after induction of general anesthesia in two-lung ventilation (TLV) and in one lung ventilation (OLV),
  • after positioning in lateral/semilateral decubitus in TLV and OLV,
  • after capnothorax and alveolar recruitment maneuver in OLV,
  • after 60 minutes from the ventilation set in OLV,
  • every 60 minutes from the last recruitment step and/or alveolar recruitment maneuver in OLV,
  • at the end of the capnothorax and in the supine position in TLV. After waking up, the LUS score (Lung Ultrasound) will be evaluated on the unoperated lung.

For the analysis of primary and secondary endpoints, appropriate descriptive and inferential statistical methodologies will be used. Continuous variables will be summarized using means and standard deviations in the case of normal distribution, while medians and interquartile ranges will be used for variables with non-normal distribution. Categorical variables will be described with absolute frequencies and percentages. This descriptive analysis will allow us to have a detailed picture of the characteristics of the population under study.

For the analysis of the primary endpoints, a repeated measures MANOVA will be used to evaluate the correlations between the P/F ratio, driving pressure and esophageal pressure during the different phases of OLV. This statistical approach is particularly suitable because it allows multiple related dependent variables to be analyzed simultaneously, providing a deeper understanding of the interactions between respiratory variables and esophageal pressure. The Greenhouse-Geisser correction will be applied if necessary to account for any violations of the sphericity assumption. The Greenhouse-Geisser correction will be applied if necessary to account for any violations of the sphericity assumption. According to the analysis performed with G*Power, an f test was used for a repeated measures MANOVA with a single group and four measurements. The effect size (f) was set at 0.30, with a significance level (α) of 0.05 and a desired statistical power of 0.90. The correlation between repeated measurements was taken to be 0.2 and the non-sphericity correction (ε) was set to 0.8. The results of the analysis indicated a noncentrality parameter (λ) of 16.20, with a critical f value of 2.89. The degrees of freedom of the numerator and denominator are 3.0 and 33.0, respectively. The total sample size required was found to be 36 participants, with an effective power of 0.904, which meets the intended goal of statistical power. Since the study involves only one group and the postoperative complications variable is binary (present/absent), the binomial test will be used to describe the proportion of patients who develop postoperative complications compared to a theoretical expected proportion of 20%, obtained from the literature. This test was chosen because it is suitable for small samples and allows for a significant statistical evaluation of postoperative complications without the need to correlate this variable with other categorical variables. This approach will provide an accurate overview of complications within the study population. A value of p < 0.05 will be considered statistically significant. Results will be reported as mean ± sd for continuous variables. Statistical analysis will be performed using Rstudio software (version 2023.09.0+351). Furthermore, the sample size calculation was performed with the G*Power software (version 3.1).

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Gianluigi Lauro, Principal investigator
  • Phone Number: +39 3663875099
  • Email: gialauro@gmail.com

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Azienda Ospedaliera di Rilievo Nazionale ed Alta Specializzazione "Antonio Cardarelli"
        • Contact:
        • Contact:
        • Contact:
          • Gianluigi Lauro
        • Contact:
          • Maria Civita Mazza
        • Contact:
          • antonio di fuccia
        • Contact:
          • gilda scognamiglio
        • Contact:
          • vincenzo maffei
        • Contact:
          • aniello alfieri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from the AORN "Antonio Cardarelli" of Naples undergoing robotic thoracic surgery will be selected and will receive one-lung ventilation during general anesthesia with the capnothorax

Description

Inclusion Criteria:

  • Age over 18 years • Patients to undergo robotic thoracic surgery with capnothorax

Exclusion Criteria:

  • Pre-existing cardiac and/or pulmonary pathologies resulting in an ASA > 3

    • Contraindications to the placement of a nasogastric tube
    • Severe COPD (stage 3 or 4)
    • Emergency thoracotomy or sternotomy for surgical complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CapnoPes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the P/F ratio (PaO2/ FiO2), the driving pressure during the OLV phases in relation to the esophageal pressure.
Time Frame: from induction of general anesthesia to awakening
Evaluate the P/F ratio (PaO2/ FiO2) and the driving pressure (the difference between plateau pressure and PEEP, during the OLV phases in relation to the esophageal pressure.
from induction of general anesthesia to awakening

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P/F upon awakening from general anesthesia and evaluate postoperative respiratory complications
Time Frame: within 24 hours post-operatively
Evaluate the P/F upon awakening from general anesthesia and evaluate post-operative respiratory complications with the LUS score.The LUS (Lung Ultrasound Score) is a scoring system used to assess lung involvement. It is based on ultrasound images of the lungs, where different areas of the chest are evaluated for the presence of B-lines, consolidations, and other abnormalities. Each lung zone is scored, helping to classify the severity of the condition and monitor its clinical progression. This method is non-invasive and effective for real-time assessment.
within 24 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardarelli Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2025

Primary Completion (Estimated)

February 20, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 15, 2025

First Submitted That Met QC Criteria

February 19, 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 23, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7029012025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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