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临床试验/NCT07161271
NCT07161271招募中不适用

Retrospective Cohort Study of Low-Flow Extracorporeal Carbon Dioxide Removal (ECCO2R) System: Evaluating Efficacy and Safety

Hong Kong University1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
59
试验地点
1
主要终点
Around 60 participants with respiratory failure as assessed for their clinical characteristics and outcomes

研究概览

简要总结

This is an observational study performed by retrospective review of data routinely collected for patients receiving low-flow extracorporeal carbon dioxide removal (ECCO2R) therapy in intensive care units (ICUs). Our aim is to firstly, describe the local practice in terms of patient selection and technical details of clinical management related to the use of low-flow ECCO2R system, and secondly, the clinical results in terms of patient outcomes and adverse events. These findings may allow clinicians to improve the quality and safety of ECCO2R therapy provision in the ICU.

详细描述

Extracorporeal carbon dioxide removal (ECCO2R) is a specialised medical procedure employed to eliminate excessive carbon dioxide (CO2) from the bloodstream. To date, there have been only a few small-scale studies published on ECCO2R, with limited data on the full spectrum of clinical presentations, management strategies, and outcomes. Previous clinical trials have investigated the potential for ECCO2R therapy to reduce the intensity of mechanical ventilation in patients suffering from acute respiratory distress syndrome (ARDS). While these trials have successfully achieved desired physiological outcomes, they have not consistently translated into improved patient mortality rates. Additionally, the use of ECCO2R has presented certain complications, especially when higher-flow ECCO2R systems based on the centrifugal pump technology were used, which had been more extensively studied in the past. However, our clinical experience appeared to suggest that low-flow ECCO2R therapy could be managed with reasonable treatment success rate and limited complications. The investigators hypothesise that the use of low-flow ECCO2R therapy is clinically effective and safe for a selected group of ICU patients with acute respiratory failure.

研究设计

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

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 supported with ECCO2R in one of the designated study sites
  • Admitted to the ICU between 1 Jan 2022 and 30 June 2024

排除标准

  • Patients younger than 18 years old

结局指标

主要结局

Around 60 participants with respiratory failure as assessed for their clinical characteristics and outcomes

时间窗: From November 2024 to September 2026 (Anticipated)

The primary endpoint is to describe the patients' demographics (e.g. Age, Sex), clinical characteristics (e.g. APACHE score, ventilator using time, respiratory parameters, ventilatory parameters, Mortality), outcomes of patients (death or survive) who received ECCO2R therapy. The secondary endpoints are to evaluate the association between clinical factors and patient outcomes (e.g. life of stay in ICU, ventilator free days), and to identify potential risk factors for adverse events and complications.

次要结局

未报告次要终点

研究者

发起方
Hong Kong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Sin Wai-ching

Doctor; Director and Clinical Associate Professor

Hospital Authority, Hong Kong

研究点 (1)

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