Patient-Ventilator Asynchrony: Occurence and Clinical Impact in Usual Care
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: PVA classification software.
- Кому может быть актуально
- Состояния в реестре: Mechanical Ventilation, Patient-Ventilator Asynchrony. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Unraveling the Clinical Impact of Patient-Ventilator Asynchrony in Usual Care
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое PVA classification software
Patients will receive standard care, without an intervention. Data will be captured as part of standard care and analyzed for PVAs retrospectively, using dedicated offline software.
Первичные конечные точки
- Asynchrony index over time (aggregated and per PVA type) [Срок оценки: 28 days]
Вторичные конечные точки (12)
- Use of sedatives (cumulative dose and type) [Срок оценки: 28 days]
- Mechanical ventilation settings [Срок оценки: 28 days]
- Respiratory parameters [Срок оценки: 28 days]
- Hemodynamic parameters [Срок оценки: 28 days]
- Relevant medication [Срок оценки: 28 days]
- Use of assist devices [Срок оценки: 28 days]
- Gas exchange parameters [Срок оценки: 28 days]
- Blood inflammatory biomarkers [Срок оценки: 28 days]
- Sedation depth [Срок оценки: 28 days]
- Reported delirium [Срок оценки: 28 days]
- Illness severity score (SOFA-score) [Срок оценки: 28 days]
- ICU mortality [Срок оценки: 90 days]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- (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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Нидерланды · 3 центра
- Catharina Ziekenhuis Eindhoven (CZE) — Eindhoven
- Leiden University Medical Center (LUMC) — Leiden
- Erasmus Medical Center (EMC) — Rotterdam
Идентификаторы
NCT: NCT07624786 · MEC-2025-0353 · EMCLSH24018