Ventilator-Induced Lung InjuryPEEP-RATSNCT06026670
Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery
An observational study of Ventilator-Induced Lung Injury, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Minimally invasive thoracic surgery is increasingly popular. Recently, a new minimally invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. RATS presents some advantages compared to VATS such as three-dimensional view of the surgical field, its precisions facilitates the navigation… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Ventilator-Induced Lung Injury
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jul 2023to 26 Feb 2024
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 120 years
- All sexes
- Adult, Older adult
Study population: ASA physical status I to III admitted to Hospital Clínic de Barcelona undergoing elective RATS lung resection who agree to participate in the study and sign the written consent form
Who may be able to join
- ASA physical status I to III
- Admitted to Hospital Clínic de Barcelona
- Undergoing elective RATS lung resection
- Who agree to participate in the study and sign the written consent form.
Who cannot join
- Patients with age <18 years
- ASA physical status IV
- Pneumonectomy
- New York Heart Association III to IV
- Preoperative hemoglobin <10 mg/dL will be excluded from the study.
- Patients in which recruitment maneuvers are contraindicated (history of pneumothorax, contralateral pulmonary bulla, hemodynamic instability, lung emphysema, COPD, bronchopleural fistula, acute cor pulmonale or intracranial hypertension).
Trial locations and contacts
1 site in 1 country.
About this study
Minimally invasive thoracic surgery is increasingly popular. Recently, a new minimally invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. RATS presents some advantages compared to VATS such as three-dimensional view of the surgical field, its precisions facilitates the navigation in difficult to access spaces and eliminates tremor which reduces learning curve and it may have a reduction of complications.
During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also a continuous tension capnothorax. CO2 insufflation with intrathoracic positive pressure has a potential negative impact on the cardiorespiratory physiology. Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung injury which are related to pulmonary postoperative complications (PPC).
Read more
In order to reduce PPC and ventilation induced lung injury, lung protective strategies are used which reduce atelectrauma and overdistension. These strategies consist of three main pillars: use of low tidal volumes, performance of recruitment maneuvers and application of optimal positive end-expiratory pressure (PEEP).
However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical studies with one-lung ventilation have reported improved oxygenation and ventilation when an alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O. Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation and lung mechanics with individualized PEEP determined by using a PEEP decrement titration trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS may modify pulmonary compliance and optimal PEEP may be different from patients having VATS resection.
Even though both methods are habitual in the clinical practice, there are no studies of the effect of an alveolar recruitment maneuver with individualized PEEP during one-lung ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in RATS compared with the establishment of a standardized PEEP. The investigators perform a descriptive observational prospective study to test this hypothesis.
Read the detailed description
Minimally invasive thoracic surgery is increasingly popular thanks to its potential benefits, including less pain, reduced surgical stress and systemic inflammatory response and reduced length of stay. In fact, video-assisted thoracoscopic surgery (VATS), is recommended for lung resection in early stages in ERAS Guidelines. Recently, a new minimally invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. Its main indications are lung resection, diaphragmatic repair, esophagectomy and resection of mediastinal tumor. RATS presents some advantages compared to VATS such as three-dimensional view of the surgical field, its precisions facilitates the navigation in difficult to access spaces, it improves work ergonomics and eliminates tremor which reduces learning curve and it may have a reduction of complications.
During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also a continuous tension capnothorax. Intrathoracic CO2 insufflation aims both to retract tissues and expand the surgical field which gives a better view of intrathoracic structures but also to facilitate anatomical dissection. Nevertheless, CO2 insufflation with intrathoracic positive pressure has a potential negative impact on the cardiorespiratory physiology: it may increase respiratory airway pressure, it may cause hypercapnia and respiratory acidosis and can compromise the hemodynamics induced by the compression of the mediastinal vessels. Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung injury which are related to pulmonary postoperative complications (PPC).
In order to reduce PPC and ventilation induced lung injury, lung protective strategies are used which reduce atelectrauma and overdistension. These strategies consist of three main pillars: use of low tidal volumes, performance of recruitment maneuvers and application of optimal positive end-expiratory pressure (PEEP).
However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical studies with one-lung ventilation have reported improved oxygenation and ventilation when an alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O. Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation and lung mechanics with individualized PEEP determined by using a PEEP decrement titration trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS may modify pulmonary compliance and optimal PEEP may be different from patients having VATS resection.
Even though both methods are habitual in the clinical practice, there are no studies of the effect of an alveolar recruitment maneuver with individualized PEEP during one-lung ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in RATS compared with the establishment of a standardized PEEP. The investigators perform a descriptive observational prospective study to test this hypothesis.
An individualized open lung approach which will consist in an alveolar recruitment maneuver followed by a positive end-expiratory pressure adjusted to best respiratory system compliance will be performed before and after capnothorax establishment.
The main expected benefits will be improvement of oxygenation, ventilation and lung mechanics.
Recruitment maneuvers are part of daily practice during mechanical ventilation. During OLV, they are done systematically, but little is known of optimal PEEP after it. When performed correctly, considering its contraindications and appropriate monitoring they are safe technique (9)
This is a single center (Hospital Clínic de Barcelona), prospective, intraoperative descriptive study. The hypothesis is to demonstrate the change in individualized optimal PEEP before and after capnothorax during OLV and the improvement of ventilation and lung mechanics. The primary objective is to assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP during capnothorax.The secondary objectives is to report the incidence of associated perioperative complications. With the purpose of standardizing the optimal respiratory management of patients that undergo robotic-assisted thoracic surgery (RATS).
Based on previous studies, it was estimated that a total of 30 patients will be needed to detect at least a 10% of static compliance during the establishment of capnothorax in one-lung ventilation, with a 5% significance level and 80% power.
Candidates for this study will be identified at the scheduled visit, prior to surgery, with one of the anaesthetists of the Cardiothoracic Anaesthesia section of our hospital. This visit is usually carried several days or weeks before surgery. Once a potential participant has been identified, the main investigator (R.N.) will offer the possibility to explain the study during the same scheduled visit and they will also provide written information regarding our study. Those who, subsequently, express their potential desire to participate in the study will also be offered an informed consent sheet for their signature. For those still willing to consider their participation but not ready to decide whether to accept or not their inclusion as part of the study, a second visit will be done once the patient is admitted to the hospital the day before the surgery.
The inclusion criteria are patients with ASA physical status I to III admitted to Hospital Clínic de Barcelona undergoing elective RATS lung resection who agree to participate in the study and sign the written consent form.
The exclusion criteria are patients with age <18 years, ASA physical status IV, pneumonectomy, New York Heart Association III to IV, and preoperative hemoglobin <10 mg/dL will be excluded from the study. Moreover, patients in which recruitment maneuvers are contraindicated will also be excluded from the study. Contraindications for recruitment maneuvers are: history of pneumothorax, contralateral pulmonary bulla, hemodynamic instability, lung emphysema, COPD, bronchopleural fistula, acute cor pulmonale or intracranial hypertension .
Data will be inspected and tested for distribution according to Kolmogorove Smirnov test. Normally distributed data were compared between study arms using the unpaired T-student test, whereas non-normally distributed data were compared using the Mann Whitney U test. All data were summarised as mean or median as appropriate. Fisher's exact test was used for comparing categorical data.
All patients included in the study will be assigned an identification code. In a separated database, the main investigator will have the relation between the identification code and the patient's clinical record number. All investigators of the study will have access to the coded number database that will be stored in a shared Drive document, and the main investigator will be responsible for it. Both database will be stored 5 years after study completion.
Individual data, such as participant baseline medical conditions, type of surgery, respiratory parameters, results from arterial gasometries samples and postoperative pulmonary complications until the 7th day from the admission will be recorded in order to assess the benefit of optimal PEEP before and after capnothorax stablishment.
- Conditions
- Ventilator-Induced Lung Injury
- Keywords
- Optimal PEEP, Robotic-Assisted Thoracic Surgery., Recruitment Maneuvers, Mechanical Ventilation, One-lung ventilation, Capnothorax, Positive End-Expiratory Pressure
- Medical subject headings
- Ventilator-Induced Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal PEEP
Assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP during capnothorax.
Measured: 4 hours
Secondary outcomes (1)
Perioperative complications
Report the incidence of associated perioperative complications
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start3 Jul 2023
- Primary completion20 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026670
- Sponsor's protocol ID
- HCB/2023/0147
- Acronym
- PEEP-RATS
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT06026670
- Acronym / sponsor ID
- PEEP-RATS / HCB/2023/0147
- Conditions
- Ventilator-Induced Lung Injury
- Keywords
- Optimal PEEP, Robotic-Assisted Thoracic Surgery., Recruitment Maneuvers, Mechanical Ventilation, One-lung ventilation, Capnothorax, Positive End-Expiratory Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 7 Sep 2023 (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.
Minimally invasive thoracic surgery is increasingly popular. Recently, a new minimally invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. RATS presents some advantages compared to VATS such as three-dimensional view of the surgical field, its precisions facilitates the navigation in difficult to access spaces and eliminates tremor which reduces learning curve and it may have a reduction of complications.
During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also a continuous tension capnothorax. CO2 insufflation with intrathoracic positive pressure has a potential negative impact on the cardiorespiratory physiology. Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung injury which are related to pulmonary postoperative complications (PPC).
In order to reduce PPC and ventilation induced lung injury, lung protective strategies are used which reduce atelectrauma and overdistension. These strategies consist of three main pillars: use of low tidal volumes, performance of recruitment maneuvers and application of optimal positive end-expiratory pressure (PEEP).
However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical studies with one-lung ventilation have reported improved oxygenation and ventilation when an alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O. Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation and lung mechanics with individualized PEEP determined by using a PEEP decrement titration trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS may modify pulmonary compliance and optimal PEEP may be different from patients having VATS resection.
Even though both methods are habitual in the clinical practice, there are no studies of the effect of an alveolar recruitment maneuver with individualized PEEP during one-lung ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in RATS compared with the establishment of a standardized PEEP. The investigators perform a descriptive observational prospective study to test this hypothesis.
Detailed description
Minimally invasive thoracic surgery is increasingly popular thanks to its potential benefits, including less pain, reduced surgical stress and systemic inflammatory response and reduced length of stay. In fact, video-assisted thoracoscopic surgery (VATS), is recommended for lung resection in early stages in ERAS Guidelines. Recently, a new minimally invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. Its main indications are lung resection, diaphragmatic repair, esophagectomy and resection of mediastinal tumor. RATS presents some advantages compared to VATS such as three-dimensional view of the surgical field, its precisions facilitates the navigation in difficult to access spaces, it improves work ergonomics and eliminates tremor which reduces learning curve and it may have a reduction of complications.
During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also a continuous tension capnothorax. Intrathoracic CO2 insufflation aims both to retract tissues and expand the surgical field which gives a better view of intrathoracic structures but also to facilitate anatomical dissection. Nevertheless, CO2 insufflation with intrathoracic positive pressure has a potential negative impact on the cardiorespiratory physiology: it may increase respiratory airway pressure, it may cause hypercapnia and respiratory acidosis and can compromise the hemodynamics induced by the compression of the mediastinal vessels. Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung injury which are related to pulmonary postoperative complications (PPC).
In order to reduce PPC and ventilation induced lung injury, lung protective strategies are used which reduce atelectrauma and overdistension. These strategies consist of three main pillars: use of low tidal volumes, performance of recruitment maneuvers and application of optimal positive end-expiratory pressure (PEEP).
However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical studies with one-lung ventilation have reported improved oxygenation and ventilation when an alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O. Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation and lung mechanics with individualized PEEP determined by using a PEEP decrement titration trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS may modify pulmonary compliance and optimal PEEP may be different from patients having VATS resection.
Even though both methods are habitual in the clinical practice, there are no studies of the effect of an alveolar recruitment maneuver with individualized PEEP during one-lung ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in RATS compared with the establishment of a standardized PEEP. The investigators perform a descriptive observational prospective study to test this hypothesis.
An individualized open lung approach which will consist in an alveolar recruitment maneuver followed by a positive end-expiratory pressure adjusted to best respiratory system compliance will be performed before and after capnothorax establishment.
The main expected benefits will be improvement of oxygenation, ventilation and lung mechanics.
Recruitment maneuvers are part of daily practice during mechanical ventilation. During OLV, they are done systematically, but little is known of optimal PEEP after it. When performed correctly, considering its contraindications and appropriate monitoring they are safe technique (9)
This is a single center (Hospital Clínic de Barcelona), prospective, intraoperative descriptive study. The hypothesis is to demonstrate the change in individualized optimal PEEP before and after capnothorax during OLV and the improvement of ventilation and lung mechanics. The primary objective is to assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP during capnothorax.The secondary objectives is to report the incidence of associated perioperative complications. With the purpose of standardizing the optimal respiratory management of patients that undergo robotic-assisted thoracic surgery (RATS).
Based on previous studies, it was estimated that a total of 30 patients will be needed to detect at least a 10% of static compliance during the establishment of capnothorax in one-lung ventilation, with a 5% significance level and 80% power.
Candidates for this study will be identified at the scheduled visit, prior to surgery, with one of the anaesthetists of the Cardiothoracic Anaesthesia section of our hospital. This visit is usually carried several days or weeks before surgery. Once a potential participant has been identified, the main investigator (R.N.) will offer the possibility to explain the study during the same scheduled visit and they will also provide written information regarding our study. Those who, subsequently, express their potential desire to participate in the study will also be offered an informed consent sheet for their signature. For those still willing to consider their participation but not ready to decide whether to accept or not their inclusion as part of the study, a second visit will be done once the patient is admitted to the hospital the day before the surgery.
The inclusion criteria are patients with ASA physical status I to III admitted to Hospital Clínic de Barcelona undergoing elective RATS lung resection who agree to participate in the study and sign the written consent form.
The exclusion criteria are patients with age <18 years, ASA physical status IV, pneumonectomy, New York Heart Association III to IV, and preoperative hemoglobin <10 mg/dL will be excluded from the study. Moreover, patients in which recruitment maneuvers are contraindicated will also be excluded from the study. Contraindications for recruitment maneuvers are: history of pneumothorax, contralateral pulmonary bulla, hemodynamic instability, lung emphysema, COPD, bronchopleural fistula, acute cor pulmonale or intracranial hypertension .
Data will be inspected and tested for distribution according to Kolmogorove Smirnov test. Normally distributed data were compared between study arms using the unpaired T-student test, whereas non-normally distributed data were compared using the Mann Whitney U test. All data were summarised as mean or median as appropriate. Fisher's exact test was used for comparing categorical data.
All patients included in the study will be assigned an identification code. In a separated database, the main investigator will have the relation between the identification code and the patient's clinical record number. All investigators of the study will have access to the coded number database that will be stored in a shared Drive document, and the main investigator will be responsible for it. Both database will be stored 5 years after study completion.
Individual data, such as participant baseline medical conditions, type of surgery, respiratory parameters, results from arterial gasometries samples and postoperative pulmonary complications until the 7th day from the admission will be recorded in order to assess the benefit of optimal PEEP before and after capnothorax stablishment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- ASA physical status I to III admitted to Hospital Clínic de Barcelona undergoing elective RATS lung resection who agree to participate in the study and sign the written consent form
Key inclusion criteria (4 listed)
- ASA physical status I to III
- Admitted to Hospital Clínic de Barcelona
- Undergoing elective RATS lung resection
- Who agree to participate in the study and sign the written consent form.
Key exclusion criteria (6 listed)
- Patients with age <18 years
- ASA physical status IV
- Pneumonectomy
- New York Heart Association III to IV
- Preoperative hemoglobin <10 mg/dL will be excluded from the study.
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
Optimal PEEP
Time frame: 4 hours
Assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP during capnothorax.
1 secondary outcome
Perioperative complications
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Ventilator-Induced Lung Injury, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal PEEP (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.