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.

NCT06837636 | Not Yet Recruiting

• 1 other identifier: 7029012025
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Capnothorax; One Lung Ventilation; Thoracic Surgery; Esophageal Pressure Measurement

Keywords

capnothorax; one lung ventilation; esophageal pressure; thoracic surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  from induction of general anesthesia to awakening

Secondary Outcomes (1)

• P/F upon awakening from general anesthesia and evaluate postoperative respiratory complications

  within 24 hours post-operatively

Study Arms (1)

CapnoPes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardarelli Hospital: lead

Study Sites (1)

Azienda Ospedaliera di Rilievo Nazionale ed Alta Specializzazione "Antonio Cardarelli"

Napoli, 80131, Italy

Location

Related Publications (10)

• Cammarota G, Lauro G, Santangelo E, Sguazzotti I, Perucca R, Verdina F, Boniolo E, Tarquini R, Bignami E, Mongodi S, Arisi E, Orlando A, Della Corte F, Vaschetto R, Mojoli F. Mechanical Ventilation Guided by Uncalibrated Esophageal Pressure May Be Potentially Harmful. Anesthesiology. 2020 Jul;133(1):145-153. doi: 10.1097/ALN.0000000000003327.

  PMID: 32349074 BACKGROUND

• Yoshida T, Amato MBP, Grieco DL, Chen L, Lima CAS, Roldan R, Morais CCA, Gomes S, Costa ELV, Cardoso PFG, Charbonney E, Richard JM, Brochard L, Kavanagh BP. Esophageal Manometry and Regional Transpulmonary Pressure in Lung Injury. Am J Respir Crit Care Med. 2018 Apr 15;197(8):1018-1026. doi: 10.1164/rccm.201709-1806OC.

  PMID: 29323931 BACKGROUND

• Wang QY, Zhou Y, Wang MR, Jiao YY. Effects of starting one lung ventilation and applying individualized PEEP right after patients are placed in lateral decubitus position on intraoperative oxygenation for patients undergoing thoracoscopic pulmonary lobectomy: study protocol for a randomized controlled trial. Trials. 2024 Jul 22;25(1):500. doi: 10.1186/s13063-024-08347-8.

  PMID: 39039591 BACKGROUND

• Gattinoni L, Chiumello D, Carlesso E, Valenza F. Bench-to-bedside review: chest wall elastance in acute lung injury/acute respiratory distress syndrome patients. Crit Care. 2004 Oct;8(5):350-5. doi: 10.1186/cc2854. Epub 2004 May 7.

  PMID: 15469597 BACKGROUND

• Ferrando C, Carraminana A, Pineiro P, Mirabella L, Spadaro S, Librero J, Ramasco F, Scaramuzzo G, Cervantes O, Garutti I, Parera A, Argilaga M, Herranz G, Unzueta C, Vives M, Regi K, Costa-Reverte M, Sonsoles Leal M, Nieves-Alonso J, Garcia E, Rodriguez-Perez A, Farina R, Cabrera S, Guerra E, Gallego-Ligorit L, Herrero-Izquierdo A, Valles-Torres J, Ramos S, Lopez-Herrera D, De La Matta M, Gokhan S, Kucur E, Mugarra A, Soro M, Garcia L, Sastre JA, Aguirre P, Salazar CJ, Ramos MC, Morocho DR, Trespalacios R, Ezequiel-Fernandez F, Lamanna A, Pia Cantatore L, Laforgia D, Bellas S, Lopez C, Navarro-Ripoll R, Martinez S, Vallverdu J, Jacas A, Yepes-Temino MJ, Belda FJ, Tusman G, Suarez-Sipmann F, Villar J; iPROVE-OLV Research Network Group. Individualised, perioperative open-lung ventilation strategy during one-lung ventilation (iPROVE-OLV): a multicentre, randomised, controlled clinical trial. Lancet Respir Med. 2024 Mar;12(3):195-206. doi: 10.1016/S2213-2600(23)00346-6. Epub 2023 Dec 5.

  PMID: 38065200 BACKGROUND

• Kiss T, Wittenstein J, Becker C, Birr K, Cinnella G, Cohen E, El Tahan MR, Falcao LF, Gregoretti C, Granell M, Hachenberg T, Hollmann MW, Jankovic R, Karzai W, Krassler J, Loop T, Licker MJ, Marczin N, Mills GH, Murrell MT, Neskovic V, Nisnevitch-Savarese Z, Pelosi P, Rossaint R, Schultz MJ, Neto AS, Severgnini P, Szegedi L, Vegh T, Voyagis G, Zhong J, de Abreu MG, Senturk M; PROTHOR investigators and the Research Workgroup PROtective VEntilation Network (PROVEnet) of the European Society of Anaesthesiology (ESA). Correction to: Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial. Trials. 2019 May 8;20(1):259. doi: 10.1186/s13063-019-3371-y.

  PMID: 31068212 BACKGROUND

• Yoon S, Nam JS, Blank RS, Ahn HJ, Park M, Kim H, Kim HJ, Choi H, Kang HU, Lee DK, Ahn J. Association of Mechanical Energy and Power with Postoperative Pulmonary Complications in Lung Resection Surgery: A Post Hoc Analysis of Randomized Clinical Trial Data. Anesthesiology. 2024 May 1;140(5):920-934. doi: 10.1097/ALN.0000000000004879.

  PMID: 38109657 BACKGROUND

• Cammarota G, Lauro G, Sguazzotti I, Mariano I, Perucca R, Messina A, Zanoni M, Garofalo E, Bruni A, Della Corte F, Navalesi P, Bignami E, Vaschetto R, Mojoli F. Esophageal Pressure Versus Gas Exchange to Set PEEP During Intraoperative Ventilation. Respir Care. 2020 May;65(5):625-635. doi: 10.4187/respcare.07238.

  PMID: 32345760 BACKGROUND

• Peel JK, Funk DJ, Slinger P, Srinathan S, Kidane B. Positive end-expiratory pressure and recruitment maneuvers during one-lung ventilation: A systematic review and meta-analysis. J Thorac Cardiovasc Surg. 2020 Oct;160(4):1112-1122.e3. doi: 10.1016/j.jtcvs.2020.02.077. Epub 2020 Feb 29.

  PMID: 32276803 BACKGROUND

• Reinius H, Borges JB, Engstrom J, Ahlgren O, Lennmyr F, Larsson A, Freden F. Optimal PEEP during one-lung ventilation with capnothorax: An experimental study. Acta Anaesthesiol Scand. 2019 Feb;63(2):222-231. doi: 10.1111/aas.13247. Epub 2018 Aug 21.

  PMID: 30132806 BACKGROUND

Central Study Contacts

Gianluigi Lauro, Principal investigator

CONTACT

+39 3663875099; gialauro@gmail.com

Maria Civita Mazza

CONTACT

+ 39 3316124698; maria_civita94@virgilio.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Gianluigi Lauro,Anesthesiologist and critical care physician working in thoracic surgery and intensive care at Cardarelli Hospital, medical director.

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: February 20, 2025
• Primary Completion: February 20, 2026
• Study Completion: March 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)