About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years • Patients to undergo robotic thoracic surgery with capnothorax
Disqualifiers
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
Trial 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
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Evaluate the P/F ratio (PaO2/ FiO2), the driving pressure during the OLV phases in relation to the esophageal pressure.
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.
Secondary outcomes
P/F upon awakening from general anesthesia and evaluate postoperative respiratory complications
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: