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临床试验/NCT07381517
NCT07381517尚未招募不适用

Correlation Between Oxygenation Indices (OI and Their Derivatives) and Oxygen Saturation Indices (OSI and Their Derivatives) During One-Lung Ventilation in Thoracic Surgery

Ankara Ataturk Sanatorium Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2026年2月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
51
试验地点
1
主要终点
Correlation between oxygenation indices and oxygen saturation indices

研究概览

简要总结

One-lung ventilation is commonly used during thoracic surgery but is frequently associated with impaired oxygenation and altered respiratory mechanics. Traditional oxygenation indices require arterial blood gas analysis and do not fully reflect the mechanical stress applied to the lungs.

This prospective observational study aims to evaluate the correlation between oxygenation indices and oxygen saturation indices during one-lung ventilation in adult patients undergoing elective thoracic surgery. Modified indices incorporating driving pressure and mechanical power will also be assessed.

No intervention beyond standard clinical care will be applied. The findings of this study may help clarify the clinical utility of non-invasive oxygenation indices for intraoperative monitoring during one-lung ventilation.

详细描述

One-lung ventilation induces complex changes in pulmonary physiology, including increased intrapulmonary shunt and altered respiratory mechanics, which may challenge conventional approaches to intraoperative oxygenation assessment. While invasive oxygenation indices are widely used, their applicability during one-lung ventilation is limited by the need for arterial blood gas sampling and the lack of integration of mechanical ventilation-related stress.

Non-invasive oxygen saturation-based indices have been proposed as alternatives; however, data regarding their performance under the dynamic physiological conditions of one-lung ventilation remain scarce. Furthermore, emerging concepts in lung-protective ventilation emphasize the importance of driving pressure and mechanical power as determinants of ventilator-induced lung injury, yet these parameters are not incorporated into traditional oxygenation metrics.

In this prospective observational study, invasive and non-invasive oxygenation indices, including modified forms incorporating driving pressure and mechanical power, will be recorded simultaneously during one-lung ventilation in adult patients undergoing elective thoracic surgery. The relationships and agreement between these indices will be analyzed to assess their comparability across different levels of mechanical respiratory load.

No intervention beyond standard clinical care will be applied. Ventilatory settings and perioperative management will be determined solely by routine clinical practice. This study is designed to provide methodological insight into the intraoperative applicability of non-invasive oxygenation indices during one-lung ventilation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years and older
  • Patients classified as ASA physical status I-III
  • Patients scheduled for elective thoracic surgery requiring one-lung ventilation for at least 1 hour intraoperatively
  • Patients in whom simultaneous arterial blood gas analysis and continuous SpO₂ monitoring can be performed
  • Patients who have provided written informed consent

排除标准

  • Patients undergoing emergency surgery
  • Patients younger than 18 years of age
  • Patients classified as ASA physical status IV or higher
  • Patients with a history of previous thoracic surgery
  • Patients with a body mass index (BMI) >40 kg/m² or <18 kg/m²
  • Patients with advanced chronic lung disease (COPD stage III-IV)
  • Patients with New York Heart Association (NYHA) class III-IV heart failure
  • Patients undergoing surgery due to pleural effusion

研究组 & 干预措施

One-Lung Ventilation Cohort

Adult patients undergoing elective thoracic surgery requiring one-lung ventilation. All patients will be managed according to standard clinical practice. No intervention is assigned as part of this observational study.

结局指标

主要结局

Correlation between oxygenation indices and oxygen saturation indices

时间窗: During intraoperative one-lung ventilation

Correlation between invasive oxygenation indices (oxygenation index and its derivatives) and non-invasive oxygen saturation indices (oxygen saturation index and its derivatives) measured during one-lung ventilation.

次要结局

未报告次要终点

研究者

发起方
Ankara Ataturk Sanatorium Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Onur KARSLIOĞLU

Resident Physician in Anesthesiology

Ankara Ataturk Sanatorium Training and Research Hospital

研究点 (1)

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