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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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

    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)
Study groups in NCT06838091
Study groupRoleWhat they receive
group 10.5 lt/min
Receives: Other: Observational
group 20.5-1 lt/min
Receives: Other: Observational
group 31-2 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.

  1. 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.

  1. First posted20 Feb 2025
  2. Study start1 Mar 2025
  3. Primary completion1 May 2025
  4. Study completion2 May 2025

Resources

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
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

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.

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