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临床试验/NCT07184580
NCT07184580尚未招募不适用

Electrical Impendance Tomography Usage in ICU : Registry Creation

Erasme University Hospital0 个研究点目标入组 1,000 人开始时间: 2025年10月15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
1,000
主要终点
Mortality rate

研究概览

简要总结

Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, bedside imaging technique that has been in clinical use for over three decades (1).

It is primarily utilized to monitor regional lung ventilation in mechanically ventilated patients. In recent years, EIT has become a routine tool in critical care settings due to its capacity to provide real-time, bedside insights into pulmonary function. Its applications are diverse, ranging from support during non-invasive ventilation and endotracheal intubation (2) to the management of complex cases of mechanical ventilation. One of its key advantages lies in guiding the optimization of Positive End-Expiratory Pressure (PEEP) titration, which may help tailor ventilatory support to individual patients and potentially reduce the mechanical power delivered to the lungs(3,4).

Despite these benefits, current evidence does not conclusively demonstrate a reduction in mortality associated with the use of EIT in critical care (5,6). Nevertheless, EIT shows promise in several emerging areas, such as monitoring ventilation distribution during prone positioning - even in awake, non-intubated patients (7) - and in the early detection of atelectasis under various clinical conditions (8).

Recently, advancements in EIT technology have led to the development of new models capable of assessing pulmonary "pulsatility," thereby expanding the potential clinical applications of EIT beyond traditional ventilation monitoring. This feature may facilitate the bedside detection of conditions such as atelectasis, pneumonia, pleural effusion, and even pulmonary embolism (9,10).

In this context, the Intensive Care Unit at Erasme Hospital is acquiring two EIT devices to enhance diagnostic capabilities and improve the care of patients requiring either non-invasive or invasive ventilation during their ICU stay. To support the systematic implementation of these devices and enable future research, it is necessary to establish a registry documenting their clinical use within the ICU. This registry will serve as a foundation for tracking usage patterns, evaluating outcomes, and potentially contributing to future scientific studies.

Standard ICU data such as SOFA scores and SAPS II will be recorded, as is already routinely done in some registries like Epimed.

This registry will be specific to the Erasme ICU and will collect detailed data on ventilation parameters, EIT measurements, and recruitment maneuvers in patients undergoing mechanical ventilation-whether invasive or non-invasive-when the clinical team determines that a recruitment maneuver is indicated and chooses to use an EIT device for monitoring.

Data will be entered into RedCap by the attending physicians or physiotherapists responsible for the patient.

Data collection will be prospective, as it is not technically possible to automatically synchronize the recording of ventilation parameters and EIT measurements using the existing software systems.

There are no expected risks for the patients, as the procedures involved are considered standard practice in intensive care settings.

Patients may benefit from the collection of these data, as it allows for closer monitoring of ventilation parameters during their ICU stay.

As this is a registry-based study, there will be no predefined duration or fixed number of patients. However, we estimate data will be recorded over a five-year period, with an inclusion of at least 300 patients per year.

Inclusion Criteria for ICU Patients:

  • Patient aged more than 12 years old (no pediatric EIT belt)
  • Patient monitored by an EIT belt OR Patient undergoing a recruitment maneuver OR Patient undergoing prone position.

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
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Mortality rate

时间窗: up to 30 days

Assessment of mortality

次要结局

  • PaO2/FiO2 ratio(During the measurement using the EIT in the ICU)
  • Hospital mortality rate(Through hospital discharge (average of 14 days))
  • Ventilation free days(28 days since the start of ventilation)
  • Mechanical power(During the measurement using the EIT in the ICU)

研究者

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

Charles Dehout

Medical doctor, intensivist, principal investigator

Erasme University Hospital

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