CapnothoraxCapnoPesNCT06837636
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.
An observational study of Capnothorax and One Lung Ventilation, run by Cardarelli Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Capnothorax, One Lung Ventilation, Thoracic Surgery
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2025to Mar 2026
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age over 18 years • Patients to undergo robotic thoracic surgery with capnothorax
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Ospedaliera di Rilievo Nazionale ed Alta Specializzazione "Antonio Cardarelli"
Naples, 80131
Gianluigi Lauro, + 393663875099, gialauro@gmail.com
Gianluigi Lauro, + 39 3663875099, gialauro@gmail.com
About this study
Official title: 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:
Read more
- 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.
Read the 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).
- Keywords
- capnothorax, one lung ventilation, esophageal pressure, thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CapnoPes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from induction of general anesthesia to awakening
Secondary outcomes (1)
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.
Measured: within 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion20 Feb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CapnothoraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Cardarelli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluigi Lauro, Cardarelli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837636
- Sponsor's protocol ID
- 7029012025
- Acronym
- CapnoPes
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32349074Yoshida 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.
PubMed 29323931Wang 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.
PubMed 39039591Gattinoni 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.
PubMed 15469597Ferrando 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.
PubMed 38065200Kiss 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.
PubMed 31068212Yoon 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.
PubMed 38109657Cammarota 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.
PubMed 32345760Peel 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.
PubMed 32276803Reinius 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.
PubMed 30132806
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Esophageal Pressure as a Guide to Set One Lung Ventilation During Capnothorax.
- ClinicalTrials.gov ID
- NCT06837636
- Acronym / sponsor ID
- CapnoPes / 7029012025
- Keywords
- capnothorax, one lung ventilation, esophageal pressure, thoracic surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cardarelli HospitalUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CapnoPes | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Age over 18 years • Patients to undergo robotic thoracic surgery with capnothorax
Key exclusion criteria (4 listed)
- Pre-existing cardiac and/or pulmonary pathologies resulting in an ASA > 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
P/F upon awakening from general anesthesia and evaluate postoperative respiratory complications
Time frame: within 24 hours post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 32349074Cammarota 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.
- Background: PubMed 29323931Yoshida 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.
- Background: PubMed 39039591Wang 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.
- Background: PubMed 15469597Gattinoni 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.
- Background: PubMed 38065200Ferrando 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.
- Background: PubMed 31068212Kiss 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.
- Background: PubMed 38109657Yoon 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.
- Background: PubMed 32345760Cammarota 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.
- Background: PubMed 32276803Peel 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.
- Background: PubMed 30132806Reinius 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.
- Individual participant dataSharing planned: No
Related trials for Capnothorax
Enrolling by invitationObservational study
Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery Without Capnothorax
Robotic Thoracic Surgery, Mechanical Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Capnothorax and One Lung Ventilation, run by Cardarelli Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianluigi Lauro, Principal investigator (+39 3663875099, gialauro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06837636, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.