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心源性休克与心脏骤停后患者酸碱平衡紊乱及通气设置的评估:与VentilO算法比较 (VentilO CU)

2026年11月3日 更新者:François Lellouche、Laval University

心源性休克与心脏骤停后患者酸碱平衡紊乱及通气设置的评估:与VentilO算法的比较

This study aims to better understand how mechanical ventilation settings affect patients admitted to the coronary care unit after cardiac arrest or with cardiogenic shock. These patients often require mechanical ventilation, but current guidelines provide limited evidence on the best approach. Improper ventilation settings can lead to acid-base imbalances, such as respiratory acidosis or alkalosis, which may worsen patient outcomes.

The retrospective analysis will include 100 adult patients (50 post-cardiac arrest and 50 with cardiogenic shock) who were mechanically ventilated upon admission. The study has two main objectives:

Determine how often acid-base disorders occur in these patients and describe their characteristics.

Compare the initial ventilator settings chosen by clinicians with those suggested by VentilO, a decision-support algorithm.

The investigators will evaluate the potential effect of the VentilO recommendations on the first arterial (or capillary) blood gases compared to the real settings.

This information will help refine the algorithm and guide future research on improving ventilation strategies for critically ill cardiac patients.

Participation does not involve any intervention, as the study uses existing medical records.

研究概览

研究类型

观察性的

注册 (估计的)

100

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

学习地点

    • Quebec
      • Québec、Quebec、加拿大、G1V4G5
        • 招聘中
        • Insitut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
        • 接触:

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

post cardiac arrest or cardiogenic shock

描述

Inclusion Criteria:

  • Adult (Age >=18 years old)
  • Under mechanical ventilation with endotracheal tube for :

post cardiac arrest or cardiogenic shock

- Bood gases result availability up to 4 hours after coronary unit admission

Exclusion Criteria:

  • Lack of patient anthropometric data (height and weight) available in the patient record
  • No information in the record regarding the data on the humidification systems used at the time of the first blood gas test upon admission to the coronary care unit.
  • Patient stabilzed in other hospital before coronary unit admission or adjustment of respiratory parameters after a blood gas test.

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

  • 观测模型:COHORT
  • 时间观点:RETROSPECTIVE

队列和干预

团体/队列
干预/治疗
心脏骤停后患者

Blood gases evaluation after initiation of mechanical ventilation

心源性休克患者

Blood gases evaluation after initiation of mechanical ventilation

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
Acid-base disorder (respiratory acidosis)
大体时间:Up to 4 hours after admission to the coronary care unit - First blood gas sample

Presence of respiratory acisosis define by pH< 7.35 and PaCO2 > 45 mmHg

Up to 4 hours after admission to the coronary care unit - First blood gas sample
Acid-base disorder (respiratory alcalosis)
大体时间:Up to 4 hours after admission to the coronary care unit - First blood gas sample

Presence of respiratory alcalosis define by by pH>7.45 and PaCO2 < 35 mmHg

Up to 4 hours after admission to the coronary care unit - First blood gas sample

次要结果测量

结果测量
措施说明
大体时间
Ventilator setting (Respiratory rate)
大体时间:Up to 4 hour after coronary unit admission - At the last ventilator setting before blood gas sample

Respiratory rate set by the doctor, these setting will be compared to the suggestion of the algorithm

Up to 4 hour after coronary unit admission - At the last ventilator setting before blood gas sample
Ventilator setting (Tidal volume)
大体时间:Up to 4 hour after coronary unit admission - At the last ventilator setting before blood gas sample

Tidal volume set by the doctor, these setting will be compared to the suggestion of the algorithm

Up to 4 hour after coronary unit admission - At the last ventilator setting before blood gas sample
Acid-base disorder (metabolic acidosis)
大体时间:Up to 4 hours after admission to the coronary care unit - First blood gas sample

Presence of metabolic acidosis define by HCO3 < 20 mmol/L

Up to 4 hours after admission to the coronary care unit - First blood gas sample
Acid-base disorder (metabolic alcalosis)
大体时间:Up to 4 hours after admission to the coronary care unit - First blood gas sample

Presence of metabolic acidosis define by HCO3 > 28 mmol/L

Up to 4 hours after admission to the coronary care unit - First blood gas sample
Optimal acid-base result
大体时间:Up to 4 hours after admission to the coronary care unit - First blood gas sample

Presence of optimal pH (7.35-7.45) with optimal PCO2 (35-45 mmHg)

Up to 4 hours after admission to the coronary care unit - First blood gas sample
Mechanical ventilation duration
大体时间:Up to 90 days

Time spent with invasive mechanical ventilation aftercoronary unit admission and hospital discharge

Up to 90 days
Vasopressor duration
大体时间:Day 28

Duration of vasopressor or inotrop administration

Day 28
Hospital length of stay
大体时间:Up to 90 days

Coronary unit admission through hospital discharge

Up to 90 days
Mortality
大体时间:Day 28

Mortality at coronary unit

Day 28
Acute renal failure
大体时间:Up to 90 days. Coronary unit stay - admission through discharge or until death if occured

Rate of acute renal failure during coronary unit length of stay. Renal failure will be defined according to the usual criteria, i.e., an increase of >27 mmol/L creatinine in 48 hours or 1.5x over the baseline

Up to 90 days. Coronary unit stay - admission through discharge or until death if occured

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。

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 (实际的)

2026年6月9日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年3月5日

首先提交符合 QC 标准的

2026年3月18日

首次发布 (实际的)

2026年3月20日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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