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临床试验/NCT07085546
NCT07085546已完成不适用

The Effects of Low-Flow Sevoflurane Anesthesia on Respiratory Mechanics, Gas Exchange, and Postoperative Pulmonary Function During One-Lung Ventilation: A Prospective Observational Study

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Postoperative Oxygen Requirement

研究概览

简要总结

This prospective observational study aims to evaluate the effects of low-flow sevoflurane anesthesia on respiratory mechanics, gas exchange, and postoperative pulmonary function in patients undergoing one-lung ventilation (OLV) during thoracic surgery. The study will compare patients receiving low-flow sevoflurane anesthesia with those receiving standard-flow anesthesia, focusing on parameters such as lung compliance, arterial oxygen levels (PaO₂), and postoperative oxygen requirements.

Fifty patients scheduled for elective thoracic surgery with OLV will be included. Data will be collected intraoperatively and postoperatively, and standard anesthesia protocols will be followed according to the attending anesthesiologist's preference. The results are expected to provide new insights into the safety and efficacy of low-flow anesthesia protocols in thoracic surgery, potentially guiding future clinical practice to reduce postoperative pulmonary complications.

详细描述

One-lung ventilation (OLV) is a common technique used during thoracic surgery to optimize the surgical field and improve operative conditions. However, OLV is associated with potential complications such as hypoxemia, lung collapse, and inflammatory responses. The choice of anesthesia technique plays a critical role in minimizing these adverse effects.

Low-flow anesthesia (LFA), defined as the administration of inhalational anesthetics with a fresh gas flow rate of 1 L/min or less, offers several advantages, including reduced anesthetic consumption, better humidification of inspired gases, decreased heat loss, and more stable pulmonary gas exchange. Despite these benefits, concerns remain regarding the risk of hypoxemia and the need for careful monitoring of anesthesia depth during LFA.

This prospective, single-center, observational study will investigate the effects of low-flow sevoflurane anesthesia on respiratory mechanics, gas exchange, and postoperative pulmonary function in patients undergoing OLV for elective thoracic surgery. Patients will be allocated to either low-flow or standard-flow anesthesia groups based on routine clinical practice, without randomization. Standard anesthesia and ventilation protocols will be applied according to the attending anesthesiologist's preference.

Primary outcomes include intraoperative lung compliance, arterial oxygenation (PaO₂), and postoperative oxygen requirements. Secondary outcomes include the incidence of atelectasis, anesthetic gas consumption, and hemodynamic parameters. Data will be collected during both intraoperative and postoperative periods. The study aims to enroll 50 patients (25 per group), as determined by power analysis.

The findings of this study are expected to provide comprehensive data on the impact of low-flow sevoflurane anesthesia during OLV, particularly regarding respiratory mechanics and postoperative pulmonary function. These results may contribute to the development of safer and more effective anesthesia protocols for thoracic surgery patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 75 years American Society of Anesthesiologists (ASA) physical status I-III Scheduled for elective video-assisted thoracoscopic surgery (VATS) or thoracotomy No acute respiratory failure

排除标准

  • Severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease Body mass index (BMI) greater than 40 kg/m² Cardiac dysfunction with ejection fraction (EF) less than 40% Requirement for emergency thoracic surgery

结局指标

主要结局

Postoperative Oxygen Requirement

时间窗: 24-hour postoperative period

Static Lung Compliance

时间窗: Intraoperative period

Static lung compliance (Cstat) will be calculated using the formula: Cstat = VT / (Pplateau - PEEP), where VT is tidal volume, Pplateau is plateau pressure, and PEEP is positive end-expiratory pressure

Arterial Oxygen Pressure (PaO₂)

时间窗: Intraoperative period

Arterial oxygen pressure (PaO₂) will be measured from arterial blood gas analysis during one-lung ventilation

次要结局

未报告次要终点

研究者

发起方
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eda Cennet Caferoğlu

Dr. - Department of Anesthesiology and Reanimation

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

研究点 (1)

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