NCT06838091

Brief 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 . 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
Last Updated

May 7, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 12, 2025

Last Update Submit

May 5, 2025

Conditions

Keywords

Low-flow anesthesiathoracic surgery

Outcome Measures

Primary Outcomes (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.

    01.03.2025- 01.06.2025

Study Arms (4)

group 1

0.5 lt/min

Other: Observational

group 2

0.5-1 lt/min

Other: Observational

group 3

1-2 lt/min

Other: Observational

group 4

\> 2lt/min

Other: Observational

Interventions

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)

group 1group 2group 3group 4

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who will undergo thoracic surgery with single lung ventilation, ASA I-II-III class, 18-75 years old

You may qualify if:

  • Patients who will undergo thoracic surgery with single lung ventilation
  • ASA I-II-III class
  • years old
  • Those who have received informed consent form approval

You may not qualify if:

  • COPD and asthma diagnosis
  • History of previous thoracic surgery
  • Body mass index (BMI) \>35
  • Development of hemodynamic instability or desaturation during surgery (SpO2\<92)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam Ve Sakura Şehir Hastanesi

Istanbul, İ̇stanbul, 34480, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Doctor

Study Record Dates

First Submitted

February 12, 2025

First Posted

February 20, 2025

Study Start

March 1, 2025

Primary Completion

May 1, 2025

Study Completion

May 2, 2025

Last Updated

May 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Because it is not completed

Locations