此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery

2026年5月24日更新者：Dr. Martin Dworschak、Medical University of Vienna

Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery in Patients at Increased Risk for Severe Postoperative Pulmonary Complications

This study investigates if single lung ventilation on cardiopulmonary bypass can mitigate postoperative lung water accumulation determined by lung ultrasound in the ventilated lung as compared to the non-ventilated lung in patients at high-risk for developing severe pulmonary complications after cardiac surgery.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Martin Dworschak, MD, MBA
电话号码：41090 +43-1-40400
邮箱：martin.dworschak@meduniwien.ac.at

研究联系人备份

姓名：Edda M. Tschernko, MD, MBA
电话号码：41060 +43-1-40400
邮箱：edda.tschernko@meduniwien.ac.at

学习地点

奥地利
- State of Vienna
  - Vienna、State of Vienna、奥地利、1090
    - General hospital Vienna
    - 接触：
      
      Martin Dworschak, MD, MBA
      
      电话号码：41090 +43-1-40400
      
      邮箱：martin.dworschak@meduniwien.ac.at
    - 接触：
      
      Edda M. Tschernko, MD, MBA
      
      电话号码：41060 +43-1-40400
      
      邮箱：edda.tschernko@meduniwien.ac.at
    - 首席研究员：
      
      Martin Dworschak, MD, MBA
    - 副研究员：
      
      Edda M. Tschernko, MD, MBA
    - 副研究员：
      
      Keso Skhirtladze-Dworschak, MD
    - 副研究员：
      
      Florentina Zingher, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Patients at increased risk for postoperative pulmonary complications
Major elective cardiac surgery
Prolonged duration of cardiopulmonary bypass
Patients older than 65 years of age
Informed consent

Exclusion Criteria:

Emergency
Urgent procedures
Patients with implanted pacemakers
Patients with internal cardioverter/defibrillators
Decompensated cardiac disease
Pulmonary disease
Recent pneumonia
Need for temporary perioperative mechanical support
Patients not willing to participate
Treatment with inhaled nitric oxide

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：支持治疗
分配：不适用
介入模型：单组作业
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：Risk group Lung ventilated during cardiopulmonary bypass using single-lung ventilation via double-lumen tube.	程序：Ventilated lung This lung will be ventilated during cardiopulmonary bypass using volume-controlled ventilation with a tidal volume of 3 mL/kg ideal body weight, a PEEP of 5 cmH2O, a respiratory rate of 10/min, and a fraction of inspired oxygen of 30%. 程序：Non-ventilated lung. The contralateral lung will not be ventilated during cardiopulmonary bypass and will be allowed to collapse.

参与者组/臂

干预/治疗

有源比较器：Risk group

Lung ventilated during cardiopulmonary bypass using single-lung ventilation via double-lumen tube.

程序：Ventilated lung

This lung will be ventilated during cardiopulmonary bypass using volume-controlled ventilation with a tidal volume of 3 mL/kg ideal body weight, a PEEP of 5 cmH2O, a respiratory rate of 10/min, and a fraction of inspired oxygen of 30%.

程序：Non-ventilated lung.

The contralateral lung will not be ventilated during cardiopulmonary bypass and will be allowed to collapse.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Lung aeration score of both lungs. 大体时间：Lung ultrasound investigations will be performed at baseline, i.e., before surgery, on the day of surgery, and on day 1 and 2 after surgery in the intensive care unit.	The aeration score of each lung is the sum of the aeration scores determined in each of six lung quadrants in each lung, which can range from 0 (normal ventilation) to 3 (atelectasis/consolidation).	Lung ultrasound investigations will be performed at baseline, i.e., before surgery, on the day of surgery, and on day 1 and 2 after surgery in the intensive care unit.

次要结果测量

结果测量	措施说明	大体时间
Radiologic assessment of Kerley B lines as indicators of lung edema. 大体时间：Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.	Number of Kerley B lines in both lungs determined by chest x-ray where stage 1 (no Kerley B lines) reflects best outcome, stage 2 (Kerley B lines become visible) indicates interstitial edema, and stage 3 (increased number of Kerley B lines also in non-dependent areas and partially obscured in dependent parts of the lung) are a sign of alveolar edema.	Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
Presence of pleural effusion in chest x-ray. 大体时间：Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.	Severity assessment will be semi-quantitative with 0 = no effusion, 1 = small effusion (with blunting of the basal lung segments and the costophrenic angle), 2 = moderate effusion (fluid extents to the mid-hemithorax creating a "meniscus sign"), and 3 = massive effusion (the whole lung appears opaque with displacement of the heart to the contralateral side if located unilaterally).	Performed on the day of surgery and on day 1 and 2 after surgery on the intensive care unit.
Determination of the Global Inhomogeneity (GI) index in both lungs separately by thoracic Electrical Impedance Tomography (EIT). 大体时间：On the day of surgery and on day 1 and 2 after surgery in the intensive care unit.	Global inhomogeneity is calculated as the sum of the absolute differences between the median value of tidal variation and every single pixel value, divided by the sum of all impedance values, to normalize the calculated values. A GI index closer to 0 represents highly homogeneous (even) ventilation. Higher values (i.e., > 0.5) indicate that some parts of the lung are over-distended while others are poorly aerated or collapsed (atelectasis).	On the day of surgery and on day 1 and 2 after surgery in the intensive care unit.
Worst oxygenation (Horowitz) index measured per day during routine blood gas checks. 大体时间：Assessed on the day of surgery and on day 1 and 2 after surgery.	The Horowitz index (HI) is calculated by diving arterial oxygen partial pressure determined in the blood gas by the fraction of inspired oxygen. It will be assessed after each blood gas check and the lowest HI during one day will be entered for further statistical analysis. The degree of impaired lung function will be determined as follows: HI > 300 mmHg (healthy lung function), HI between 201-300 mmHg (mild lung injury), HI between 101-200 mmHg (moderately severely impaired lung function), and HI < 100 mmHg (severe lung injury, ARDS).	Assessed on the day of surgery and on day 1 and 2 after surgery.
Static lung compliance determined in each lung separately. 大体时间：On the day of surgery in the operating room before and after cardiac surgery on cardiopulmonary bypass when the patient is still ventilated via double lumen tube.	Static lung compliance of the ventilated and the non-ventilated lung will be determined twice for each patient. Static compliance in healthy adults ranges between 60 and 100 mL/cm H₂O. Values below 50 mL/cm H₂O would be considered abnormally low.	On the day of surgery in the operating room before and after cardiac surgery on cardiopulmonary bypass when the patient is still ventilated via double lumen tube.
Amount of released immune modulators. 大体时间：Determined on the day of surgery as well as on day 1, 2, 3, and 4 after surgery.	Serum levels for HSP70, MMP-8, MMP-9, TIMP-1, and Lipocalin-2 will be determined in patients' blood samples, with normal values ranging from 0.2-3 ng/mL for HSP70, 0.3-1.2 ng/mL for MMP-8, 14-100 ng/mL for MMP-9, 80-150 ng/mL for TIMP-1, and 20-130 ng/mL for Lipocalin-2, respectively.	Determined on the day of surgery as well as on day 1, 2, 3, and 4 after surgery.

其他结果措施

结果测量	措施说明	大体时间
Length of ICU and hospital stay. 大体时间：These variables will be censored at study completion, on average 30 days.	The duration from transfer to the intensive care unit until discharge to a step-down unit and the duration of hospitalization of the patient will be determined in days.	These variables will be censored at study completion, on average 30 days.
In-hospital mortality. 大体时间：In-hospital mortality will be censored at study completion, on average 30 days.	It will be recorded if the patient has been discharged from the hospital alive.	In-hospital mortality will be censored at study completion, on average 30 days.
Duration on respiratory support via endotracheal tube. 大体时间：The time until extubation will be censored at study completion, on average 30 days.	The hours between arrival of the intubated patient on the intensive care unit until extubation will be determined.	The time until extubation will be censored at study completion, on average 30 days.
Postoperative complications. 大体时间：All complications will be censored at study completion, on average 30 days.	Any complication that poses a risk for the patient occurring during the hospital stay and having been documented in the patient's file will be retrieved by carefully reviewing the files and recorded.	All complications will be censored at study completion, on average 30 days.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Medical University of Vienna

调查人员

首席研究员：Martin Dworschak, MD, MBA、Medical University of Vienna

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2029年7月31日

研究注册日期

首次提交

2026年4月4日

首先提交符合 QC 标准的

2026年5月24日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月24日

最后验证

2026年4月1日

Unilateral Ventilation on Cardiopulmonary Bypass During Cardiac Surgery