Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children
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: Clinical decision support system (CDSS) for ventilator weaning.
- Кому может быть актуально
- Состояния в реестре: Congenital Heart Disease. Базовые параметры: 1 Day — 12 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Обзор
The goal of this study is to evaluate the impact of a clinical decision support system (CDSS) in children receiving mechanical ventilation (MV) after surgery for congenital heart disease (CHD). The main question it aims to answer is: -What is the impact of a CDSS designed to facilitate weaning and discontinuation of MV on the duration of MV in post-operative congenital cardiac surgery patients? Participants will be identified as eligible to initiate weaning from mechanical ventilation. Providers will decide whether or not to initiate weaning based on recommendations provided by the CDSS. Researchers will compare patients exposed to the CDSS with a historical cohort to see if the CDSS facilitated a decrease in MV duration.
Подробное описание
Prolonged mechanical ventilation (MV) in children with congenital heart disease (CHD) is associated with morbidity and mortality. There is no standard approach to weaning MV in CHD patients. Similarly, extubation failure is associated with morbidity and mortality, and there is no existing method for predicting extubation success in CHD patients. The overarching aim of this study is to use a novel clinical decision support system (CDSS) informed by continuous data streams and risk analytics algorithms to facilitate shorter MV duration.
The CDSS will be built into the T3 Visualization Platform (T3). T3 continuously tracks all inputs from a patient's existing physiologic monitors, ventilator, and laboratory values from the electronic medical record. T3 then graphically displays the data on a single bedside computer/monitor that is updated every 5 seconds. The platform includes three FDA 510(k)-cleared predictive analytics algorithms for estimating the risk of low cardiac output (IDO2), inadequate ventilation (IVCO2), and acidosis (IPH). The investigators for this study have previously evaluated IDO2 and IVCO2 in a retrospective cohort of children receiving MV for greater than or equal to 48 hours following cardiac surgery. This study identified that patients with a low IDO2 and IVCO2 had a higher probability of remaining extubated without the need for reintubation or unplanned use of noninvasive ventilation in the 48 hours following extubation.
The CDSS will be designed to prompt discussion around timing of ventilator weaning, extubation readiness assessments, and extubation. Recommendations will be informed by the continuous monitoring of a patient and based on trends in vital signs and the risk analytics algorithms.
This study will be a single center, nonrandomized before and after study with additional quasi-experimental design component using interrupted time-series analysis (with retrospective evaluation of pre-intervention and prospective data collection post-intervention).
Вмешательства
- Устройство Clinical decision support system (CDSS) for ventilator weaning
A clinical decision support system (CDSS) will be integrated into a software program (the T3 platform) that is present on all patient bedside computers. The T3 platform is a tool that compiles data from a patient's existing physiologic monitors, ventilator, and laboratory results and graphically displays them on a bedside monitor. The CDSS will be active on all patients receiving mechanical ventilation, but primary use and evaluation will focus on patients meeting study criteria. Twice daily (on
Первичные конечные точки
- Duration of Mechanical Ventilation [Срок оценки: Up to 28 days after surgery]
Вторичные конечные точки (4)
- Unplanned extubation [Срок оценки: From date of surgery until date of first documented extubation, assessed up to 28 days]
- Unplanned use of noninvasive ventilation [Срок оценки: Within 48 hours of extubation]
- Unplanned reintubation [Срок оценки: Within 48 hours of extubation]
- Adherence rate by clinical team to CDSS recommendations [Срок оценки: From date of CDSS initiation until date of first documented extubation, assessed up to 28 days]
Критерии участия
Критерии включения
- Children < 12 years old
- Post-cardiac surgery
- Receiving mechanical ventilation for ≥ 48 hours in the Cardiac Intensive Care Unit at Boston Children's Hospital following surgery
Критерии исключения
- Premature infants (<37 weeks' gestation)
- Weight < 2kg
- Baseline ventilator (via tracheostomy) or noninvasive positive pressure dependence
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Boston Children's Hospital — Boston
Идентификаторы
NCT: NCT05687292 · P00044253