Thoracic SurgeryLow-Flow AnestNCT06838091
Effect of Low-Flow Anesthesia in Single Lung Ventilation on Postoperative Respiratory Complications
An observational study of Thoracic Surgery and Low-flow Anesthesia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Mechanical ventilation in thoracic surgery patients is often complicated because patients are usually in the lateral decubitus position and the operated lung is intermittently deflated to facilitate surgical exposure . Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Surgery, Low-flow Anesthesia
- What is being tested?
- Observational
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 2 May 2025
- How long will I take part?
- 1 Month
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who will undergo thoracic surgery with single lung ventilation, ASA I-II-III class, 18-75 years old
Who may be able to join
- Patients who will undergo thoracic surgery with single lung ventilation
- ASA I-II-III class
- 18-75 years old
- Those who have received informed consent form approval
Who cannot join
- COPD and asthma diagnosis
- History of previous thoracic surgery
- Body mass index (BMI) >35
- Development of hemodynamic instability or desaturation during surgery (SpO2<92)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam Ve Sakura Şehir Hastanesi
Istanbul, İ̇stanbul, 34480
About this study
Mechanical ventilation in thoracic surgery patients is often complicated because patients are usually in the lateral decubitus position and the operated lung is intermittently deflated to facilitate surgical exposure . Single-lung ventilation during thoracic surgery is prone to volutrauma, barotrauma, atelectrauma, and oxygen toxicity, which are important aspects of ventilator-associated lung injury (VILI) . In studies conducted on operated patients, the use of lung-protective ventilation, including low tidal volume (6-8 ml/kg), respiratory rate, driving pressure (DP), and positive end-expiratory pressure (PEEP) application, has been recommended in the perioperative period to reduce postoperative pulmonary complications. Optimum oxygenation should be provided to patients during the intraoperative period, avoiding the harmful effects of hypoxia and hyperoxia. This situation becomes even more important in single-lung ventilation. Fresh gas flow in anesthesia systems can be done with traditional high-flow, normal-flow, or low-flow strategies according to the clinician's preference. The interest in the anesthesia method with low fresh gas flow has increased all over the world and in our country. The development of the technology of the anesthesia devices used, the increase in knowledge about the content of inhaled gases, and the availability of monitors that continuously and thoroughly analyze the anesthetic gas composition have facilitated the use of low-flow anesthesia safely.
When the literature is evaluated, it is defined as 4 lt/min and above as very high flow, 2-4 lt/min as high flow, 1-2 lt/min as medium flow, 0.5-1 lt/min as low flow, 0.25-0.5 lt/min as minimal flow, and <0.25 lt/min as metabolic flow . High flow has now been abandoned due to both cost and environmental pollution.
Read more
Low-flow anesthesia creates a breath air closer to physiological conditions during anesthesia by heating and humidifying the inhaled gases. In addition, it provides a cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution . It is suggested that the use of both fresh gas flow rates does not pose a safety risk for patients, and in fact, the use of low-flow anesthesia methods should be made more widespread with the advantages it provides. Low-flow anesthesia is a method applied during general anesthesia using a rebreathing anesthesia system, where the rebreathed fresh oxygen flow rate is at least 50%, metabolic requirements are fully met and sufficient volatile matter can be administered. In our clinic, the fresh gas flow rate during general anesthesia is routinely used at a value between 0.5 lt/min-3 lt/min, depending on the clinician's preference. In our clinic, low-flow anesthesia methods (with varying flows) are routinely applied in addition to normal flow methods in many surgical practices.
Although low-flow anesthesia techniques are used in many surgical practices, the literature is limited in surgeries where single-lung ventilation is performed. The purpose of this study is to determine the anesthetic flows used in amounts ranging from 0.5 lt/min-3 lt/min in thoracic surgeries where single-lung ventilation is performed; to evaluate the effects on perioperative hemodynamic and respiratory parameters and respiratory complications. The secondary aim of the study is to show the consumption of inhalation agent and soda lime.
Read the detailed description
Mechanical ventilation in thoracic surgery patients is often complicated because patients are usually in the lateral decubitus position and the operated lung is intermittently deflated to facilitate surgical exposure. Single-lung ventilation during thoracic surgery is prone to volutrauma, barotrauma, atelectrauma, and oxygen toxicity, which are important aspects of ventilator-associated lung injury (VILI). In studies conducted on operated patients, the use of lung-protective ventilation, including low tidal volume (6-8 ml/kg), respiratory rate, driving pressure (DP), and positive end-expiratory pressure (PEEP) application, has been recommended in the perioperative period to reduce postoperative pulmonary complications. Optimum oxygenation should be provided to patients during the intraoperative period, avoiding the harmful effects of hypoxia and hyperoxia. This situation becomes even more important in single-lung ventilation. Fresh gas flow in anesthesia systems can be done with traditional high-flow, normal-flow, or low-flow strategies according to the clinician's preference. The interest in the anesthesia method with low fresh gas flow has increased all over the world and in our country. The development of the technology of the anesthesia devices used, the increase in knowledge about the content of inhaled gases, and the availability of monitors that continuously and thoroughly analyze the anesthetic gas composition have facilitated the use of low-flow anesthesia safely.
When the literature is evaluated, it is defined as 4 lt/min and above as very high flow, 2-4 lt/min as high flow, 1-2 lt/min as medium flow, 0.5-1 lt/min as low flow, 0.25-0.5 lt/min as minimal flow, and <0.25 lt/min as metabolic flow. High flow has now been abandoned due to both cost and environmental pollution.
Low-flow anesthesia creates a breath air closer to physiological conditions during anesthesia by heating and humidifying the inhaled gases. In addition, it provides a cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution. It is suggested that the use of both fresh gas flow rates does not pose a safety risk for patients, and in fact, the use of low-flow anesthesia methods should be made more widespread with the advantages it provides. Low-flow anesthesia is a method applied during general anesthesia using a rebreathing anesthesia system, where the rebreathed fresh oxygen flow rate is at least 50%, metabolic requirements are fully met and sufficient volatile matter can be administered. In our clinic, the fresh gas flow rate during general anesthesia is routinely used at a value between 0.5 lt/min-3 lt/min, depending on the clinician's preference. In our clinic, low-flow anesthesia methods (with varying flows) are routinely applied in addition to normal flow methods in many surgical practices.
Although low-flow anesthesia techniques are used in many surgical practices, the literature is limited in surgeries where single-lung ventilation is performed. The purpose of this study is to determine the anesthetic flows used in amounts ranging from 0.5 lt/min-3 lt/min in thoracic surgeries where single-lung ventilation is performed; to evaluate the effects on perioperative hemodynamic and respiratory parameters and respiratory complications. The secondary aim of the study is to show the consumption of inhalation agent and soda lime.
- Conditions
- Thoracic Surgery, Low-flow Anesthesia
- Being tested
- Observational
- Keywords
- Low-flow anesthesia, thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
During anesthesia administration:
T0, T1, T2, T3, T4 represent the following periods:
T0: Double lumen ventilation in the supine position immediately after intubation T1: Double lumen ventilation in the lateral position T2: Single lumen ventilation in the lateral position (with the chest wall closed) T3: Single lumen ventilation in the lateral position (with the chest wall open) T4: Just before extubation
- Airway pressure (P plateau, Ppeak) values from the anesthesia device data,
- BIS (from routine BIS monitoring)
- Temperature (Routinely from pharyngeal temperature probe),
- Oxygen saturation (Routinely from the patient monitor)
- End-tidal CO₂,
- Inspiratory O₂ concentration,
- Inspiratory CO2 concentration,
- Inspiratory and expiratory desflurane/sevoflurane concentrations,
- Tidal volume,
- MAC, routinely from anesthesia device data
- Blood Gas Analysis (COHgb, Ph, PO 2 , PCO 2 , SaO 2, HCO 3 , Base deficit, glucose, lactate)
| Study group | Role | What they receive |
|---|---|---|
| group 1 | 0.5 lt/min Receives: Other: Observational | |
| group 2 | 0.5-1 lt/min Receives: Other: Observational | |
| group 3 | 1-2 lt/min Receives: Other: Observational | |
| group 4 | > 2lt/min Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of anesthetic flows varying
Primary outcome is the effects of anesthetic flows varying between 0.5 lt/min-3 lt/min on perioperative hemodynamic and respiratory parameters and respiratory complications in thoracic surgeries with single lung ventilation.
Measured: 01.03.2025- 01.06.2025
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 start1 Mar 2025
- Primary completion1 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cansu KILINC BERKTAS, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838091
- Sponsor's protocol ID
- 243
- Acronym
- Low-Flow Anest
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: Because it is not completed
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Flow Anesthesia in Single Lung Ventilation on Postoperative Respiratory Complications
- ClinicalTrials.gov ID
- NCT06838091
- Acronym / sponsor ID
- Low-Flow Anest / 243
- Conditions
- Thoracic Surgery, Low-flow Anesthesia
- Keywords
- Low-flow anesthesia, thoracic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- 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.
Mechanical ventilation in thoracic surgery patients is often complicated because patients are usually in the lateral decubitus position and the operated lung is intermittently deflated to facilitate surgical exposure . Single-lung ventilation during thoracic surgery is prone to volutrauma, barotrauma, atelectrauma, and oxygen toxicity, which are important aspects of ventilator-associated lung injury (VILI) . In studies conducted on operated patients, the use of lung-protective ventilation, including low tidal volume (6-8 ml/kg), respiratory rate, driving pressure (DP), and positive end-expiratory pressure (PEEP) application, has been recommended in the perioperative period to reduce postoperative pulmonary complications. Optimum oxygenation should be provided to patients during the intraoperative period, avoiding the harmful effects of hypoxia and hyperoxia. This situation becomes even more important in single-lung ventilation. Fresh gas flow in anesthesia systems can be done with traditional high-flow, normal-flow, or low-flow strategies according to the clinician's preference. The interest in the anesthesia method with low fresh gas flow has increased all over the world and in our country. The development of the technology of the anesthesia devices used, the increase in knowledge about the content of inhaled gases, and the availability of monitors that continuously and thoroughly analyze the anesthetic gas composition have facilitated the use of low-flow anesthesia safely.
When the literature is evaluated, it is defined as 4 lt/min and above as very high flow, 2-4 lt/min as high flow, 1-2 lt/min as medium flow, 0.5-1 lt/min as low flow, 0.25-0.5 lt/min as minimal flow, and <0.25 lt/min as metabolic flow . High flow has now been abandoned due to both cost and environmental pollution.
Low-flow anesthesia creates a breath air closer to physiological conditions during anesthesia by heating and humidifying the inhaled gases. In addition, it provides a cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution . It is suggested that the use of both fresh gas flow rates does not pose a safety risk for patients, and in fact, the use of low-flow anesthesia methods should be made more widespread with the advantages it provides. Low-flow anesthesia is a method applied during general anesthesia using a rebreathing anesthesia system, where the rebreathed fresh oxygen flow rate is at least 50%, metabolic requirements are fully met and sufficient volatile matter can be administered. In our clinic, the fresh gas flow rate during general anesthesia is routinely used at a value between 0.5 lt/min-3 lt/min, depending on the clinician's preference. In our clinic, low-flow anesthesia methods (with varying flows) are routinely applied in addition to normal flow methods in many surgical practices.
Although low-flow anesthesia techniques are used in many surgical practices, the literature is limited in surgeries where single-lung ventilation is performed. The purpose of this study is to determine the anesthetic flows used in amounts ranging from 0.5 lt/min-3 lt/min in thoracic surgeries where single-lung ventilation is performed; to evaluate the effects on perioperative hemodynamic and respiratory parameters and respiratory complications. The secondary aim of the study is to show the consumption of inhalation agent and soda lime.
Detailed description
Mechanical ventilation in thoracic surgery patients is often complicated because patients are usually in the lateral decubitus position and the operated lung is intermittently deflated to facilitate surgical exposure. Single-lung ventilation during thoracic surgery is prone to volutrauma, barotrauma, atelectrauma, and oxygen toxicity, which are important aspects of ventilator-associated lung injury (VILI). In studies conducted on operated patients, the use of lung-protective ventilation, including low tidal volume (6-8 ml/kg), respiratory rate, driving pressure (DP), and positive end-expiratory pressure (PEEP) application, has been recommended in the perioperative period to reduce postoperative pulmonary complications. Optimum oxygenation should be provided to patients during the intraoperative period, avoiding the harmful effects of hypoxia and hyperoxia. This situation becomes even more important in single-lung ventilation. Fresh gas flow in anesthesia systems can be done with traditional high-flow, normal-flow, or low-flow strategies according to the clinician's preference. The interest in the anesthesia method with low fresh gas flow has increased all over the world and in our country. The development of the technology of the anesthesia devices used, the increase in knowledge about the content of inhaled gases, and the availability of monitors that continuously and thoroughly analyze the anesthetic gas composition have facilitated the use of low-flow anesthesia safely.
When the literature is evaluated, it is defined as 4 lt/min and above as very high flow, 2-4 lt/min as high flow, 1-2 lt/min as medium flow, 0.5-1 lt/min as low flow, 0.25-0.5 lt/min as minimal flow, and <0.25 lt/min as metabolic flow. High flow has now been abandoned due to both cost and environmental pollution.
Low-flow anesthesia creates a breath air closer to physiological conditions during anesthesia by heating and humidifying the inhaled gases. In addition, it provides a cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution. It is suggested that the use of both fresh gas flow rates does not pose a safety risk for patients, and in fact, the use of low-flow anesthesia methods should be made more widespread with the advantages it provides. Low-flow anesthesia is a method applied during general anesthesia using a rebreathing anesthesia system, where the rebreathed fresh oxygen flow rate is at least 50%, metabolic requirements are fully met and sufficient volatile matter can be administered. In our clinic, the fresh gas flow rate during general anesthesia is routinely used at a value between 0.5 lt/min-3 lt/min, depending on the clinician's preference. In our clinic, low-flow anesthesia methods (with varying flows) are routinely applied in addition to normal flow methods in many surgical practices.
Although low-flow anesthesia techniques are used in many surgical practices, the literature is limited in surgeries where single-lung ventilation is performed. The purpose of this study is to determine the anesthetic flows used in amounts ranging from 0.5 lt/min-3 lt/min in thoracic surgeries where single-lung ventilation is performed; to evaluate the effects on perioperative hemodynamic and respiratory parameters and respiratory complications. The secondary aim of the study is to show the consumption of inhalation agent and soda lime.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: Observational0.5 lt/min |
| group 2 | – | Other: Observational0.5-1 lt/min |
| group 3 | – | Other: Observational1-2 lt/min |
| group 4 | – | Other: Observational> 2lt/min |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo thoracic surgery with single lung ventilation, ASA I-II-III class, 18-75 years old
Key inclusion criteria (4 listed)
- Patients who will undergo thoracic surgery with single lung ventilation
- ASA I-II-III class
- 18-75 years old
- Those who have received informed consent form approval
Key exclusion criteria (4 listed)
- COPD and asthma diagnosis
- History of previous thoracic surgery
- Body mass index (BMI) >35
- Development of hemodynamic instability or desaturation during surgery (SpO2<92)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalDuring anesthesia administration: T0, T1, T2, T3, T4 represent the following periods: T0: Double lumen ventilation in the supine position immediately after intubation T1: Double lumen ventilation in the lateral position T2: Single lumen ventilation in the lateral position (with the chest wall closed) T3: Single lumen ventilation in the lateral position (with the chest wall open) T4: Just before extubation 1. Airway pressure (P plateau, Ppeak) values from the anesthesia device data, 2. BIS (from routine BIS monitoring) 3. Temperature (Routinely from pharyngeal temperature probe), 4. Oxygen saturation (Routinely from the patient monitor) 5. End-tidal CO₂, 6. Inspiratory O₂ concentration, 7. Inspiratory CO2 concentration, 8. Inspiratory and expiratory desflurane/sevoflurane concentrations, 9. Tidal volume, 10. MAC, routinely from anesthesia device data 11. Blood Gas Analysis (COHgb, Ph, PO 2 , PCO 2 , SaO 2, HCO 3 , Base deficit, glucose, lactate) | Other | group 1, group 2, group 3, group 4 |
Primary outcome
The effects of anesthetic flows varying
Time frame: 01.03.2025- 01.06.2025
Primary outcome is the effects of anesthetic flows varying between 0.5 lt/min-3 lt/min on perioperative hemodynamic and respiratory parameters and respiratory complications in thoracic surgeries with single lung ventilation.
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 7 May 2025.
- Individual participant dataSharing planned: No. Because it is not completed
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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 Thoracic Surgery and Low-flow Anesthesia, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 7 May 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 Turkey (Türkiye). 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?
The effects of anesthetic flows varying (time frame: 01.03.2025- 01.06.2025). 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 7 May 2025.