- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06838091
Effect of Low-Flow Anesthesia in Single Lung Ventilation on Postoperative Respiratory Complications (Low-Flow Anest)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
İ̇stanbul
-
Istanbul, İ̇stanbul, Turkey, 34480
- Başakşehir Çam ve Sakura Şehir Hastanesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- COPD and asthma diagnosis
- History of previous thoracic surgery
- Body mass index (BMI) >35
- Development of hemodynamic instability or desaturation during surgery (SpO2<92)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group 1
0.5 lt/min
|
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
|
|
group 2
0.5-1 lt/min
|
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
|
|
group 3
1-2 lt/min
|
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
|
|
group 4
> 2lt/min
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
01.03.2025- 01.06.2025
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 243
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
product manufactured in and exported from the U.S.
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