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临床试验/NCT07624786
NCT07624786招募中不适用

Unraveling the Clinical Impact of Patient-Ventilator Asynchrony in Usual Care

Erasmus Medical Center6 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年7月21日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
6

研究概览

简要总结

The goal of this observational study is to unravel the occurence, impact and relations of Patient-Ventilator Aynchrony (PVA) in mechanically ventilated patients. The main questions it aims to answer are:

  • How often does PVA occur?
  • What are relations between clinical characteristics and PVA occurence?
  • What are relations between PVA occurence and patient outcomes?

All questions will be assessed using data collected during the whole course of mechanical ventilation. Mechanically ventilated patients' medical data will be re-used. PVAs will be automatically classified on ventilator waveform data, using validated Deep Breath software.

详细描述

Many ventilated patients show excessive breathing efforts and abnormal, irregular breathing. This patient-ventilator asynchrony (PVA) is associated with serious discomfort, lung injury, sleep disruption and higher mortality. PVA exists in many forms and is reported in 10-90% of patients, but identifying and resolving it is challenging, even for expert clinicians. Hence, PVA prevalence and impact is likely highly underestimated, and the direct causal link with worse outcomes is inconclusive. PVAs should be better dettected, understood and resovled to optimize the individual patient's treatment.

In a previous study, the investigators validated an AI-based algorithm capable of reliable PVA detection (Deep Breath software). In this study, the investigators will apply this algorithm to the collected ventilator waveform data (offline processing), in order to reliably assess PVA occurrence, and its relation with clinical outcomes and patient characteristics in current clinical care. Data of minimally 110 patients collected over the whole course of mechanical ventilation will be assessed. Patients will be included in three ICUs to promote generalizability.

The primary outcome will be the asynchrony index (in total and per PVA type) over time. Secondary outcomes will include, but are not limited to: clinical characteristics (e.g. respiratory and hemodynamic parameters, sedation), (ICU) mortality, ventilator free days at day 28 and 90, duration of ventilation, weaning success and reintubation rate.

研究设计

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

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

  • Age > 18 years old.
  • Recordings available of ventilator waveforms synchronized with the patient's electronic health record during invasive mechanical ventilation.
  • Duration of mechanical ventilation of at least 24 hours.

排除标准

  • (Previous) registered objection of patient and/or relatives to re-use clinical data for research purposes
  • No consent for re-use of data for research

研究组 & 干预措施

Adult patients admitted to the ICU that receive invasive mechanical ventilation

Patients need to be >18 years old, receive mechanical ventilation for at least 24 hours and have recordings available of ventilator waveforms, synchronized with the patient's electronic health record, during invasive mechanical ventilation.

干预措施: PVA classification software (Other)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Annemijn Jonkman

Associate professor, Principal Investigator

Erasmus Medical Center

研究点 (6)

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