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临床试验/NCT07302243
NCT07302243已完成不适用

Association Between One Lung Ventilation and Myocardial Injury Markers (Troponin T and I) in Thoracic Surgical Procedures : An Observational Cohort Study (OLVTIS)

Universitas Jenderal Soedirman1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年7月1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
39
试验地点
1
主要终点
Change in Troponin T Levels Pre- and Post-Thoracotomy with One-Lung Ventilation

研究概览

简要总结

This prospective single-group cohort study aims to investigate the association between the One-Lung Ventilation (OLV) technique and myocardial injury, as measured by postoperative Troponin T and Troponin I levels, in patients undergoing thoracic surgery. All eligible participants will undergo standardized anesthesia and OLV techniques, with cardiac biomarkers collected before surgery and six hours postoperatively. The findings of this study are expected to provide a better understanding of the impact of OLV on myocardial stress or injury during thoracic surgical procedures.

详细描述

The one-lung ventilation (OLV) technique offers significant operative advantages but may cause various physiological complications that can potentially affect cardiovascular function. Intraoperative hemodynamic changes may lead to postoperative myocardial infarction and increase mortality risk. Aim To determine the differences in postoperative troponin T and I levels in thoracic surgery with OLV. This cohort study involved thirty nine patients who underwent thoracic surgery with OLV. All subjects received OLV with a ventilation ratio of 50% air to 50% oxygen, a tidal volume of 5-6 mL/kg body weight, and a respiratory rate of 12 breaths per minute. Troponin T and I levels were measured before and after surgery. Hemodynamic status and perioperative parameters were recorded.

Here is a clear, structured English version suitable for the Study Description → Detailed Description section of ClinicalTrials.gov:

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Detailed Study Procedures

Eligible participants who meet the study criteria will be identified by the research team. Each participant will receive a detailed explanation of the study objectives and procedures. Those who agree to participate will be asked to sign an informed consent form during the preoperative visit. all participants will undergo standard monitoring placement, including vital sign monitors and arterial line insertion. Patients will then be prepared for anesthesia induction.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-60 years who requiring surgical thoracotomy with one lung ventilation
  • Classified as ASA Physical Status I - III
  • Provide Informed concent ( patient or legal representative)

排除标准

  • 未提供

结局指标

主要结局

Change in Troponin T Levels Pre- and Post-Thoracotomy with One-Lung Ventilation

时间窗: Pre operative baseline and 6 - 12 hours post operative

Troponin T levels are measured before surgery and again 6-12 hours after the thoracotomy procedure to evaluate myocardial injury potentially associated with one-lung ventilation.

次要结局

未报告次要终点

研究者

发起方
Universitas Jenderal Soedirman
申办方类型
Other
责任方
Principal Investigator
主要研究者

MM Rudi Prihatno

Consultant Neuroanesthesiologist and Dean, Faculty of Medicine, Jenderal Soedirman University

Universitas Jenderal Soedirman

研究点 (1)

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