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Набор скоро начнётся NCT07109206

Cardio-circulatory and Respiratory Monitoring for Prediction of Outcome in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients

— Наблюдательное COPD (Chronic Obstructive Pulmonary Disease) Cardiometry Weaning Invasive Mechanical Ventilation

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: COPD (Chronic Obstructive Pulmonary Disease), Cardiometry, Weaning Invasive Mechanical Ventilation. 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Chronic Obstructive Pulmonary Disease (COPD) remains a leading cause of morbidity and mortality worldwide, often necessitating invasive mechanical ventilation (MV) during acute exacerbations. Weaning these patients from MV is a critical juncture in their care, as prolonged ventilation is associated with increased complications, including ventilator-associated pneumonia, diaphragmatic dysfunction, and higher healthcare costs. Traditional weaning indices, such as the Rapid Shallow Breathing Index (RSBI), Maximum Inspiratory Pressure (MIP), and the Integrative Weaning Index (IWI), New Integrative Weaning Index (NIWI) have been employed to predict weaning outcomes. However, their predictive accuracy in COPD patients is variable, often due to the heterogeneous nature of the disease and the presence of comorbidities. Recent advancements have introduced non-invasive hemodynamic monitoring tools, such as the ICON® (Electrical Cardiometry), which measures parameters like cardiac output, stroke volume, and thoracic fluid content. These parameters may offer additional insights into a patient's readiness for weaning by providing real-time data on cardiovascular and fluid status, which are crucial in the weaning process. There is a scarcity of data comparing the predictive value of ICON parameters with traditional weaning indices in COPD patients. Understanding whether ICON-derived metrics can enhance weaning predictions and lead to more individualized and effective weaning strategies, reducing the duration of MV and improving patient outcomes.

Первичные конечные точки

  • Evaluate the accuracy of non-invasive hemodynamic parameters using Electric Cardiometry to predict weaning outcome in mechanically ventilated COPD patients. [Срок оценки: 2 Years]
Вторичные конечные точки (1)
  • Evaluate respiratory indices (RSBI, IWI, MIWI) as predictors of weaning outcome in mechanically ventilated COPD patients [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • All COPD patients who are mechanically ventilated for more than 48 h due to acute exacerbation and fulfilling weaning criteria will be included in the study.

Критерии исключения

  • Patients younger than 18 years old.
  • Patients with pneumothorax, pleural, or pericardial effusion.
  • Patients with injuries, burns, or wounds which precludes the proper application of the device electrodes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Египет · 1 центр
  • Assiut University Medical School. — Asyut

Публикации

  • Hajian-Tilaki K. Receiver Operating Characteristic (ROC) Curve Analysis for Medical Diagnostic Test Evaluation. Caspian J Intern Med. 2013 Spring;4(2):627-35. PMID 24009950
  • McHugh ML. The chi-square test of independence. Biochem Med (Zagreb). 2013;23(2):143-9. doi: 10.11613/bm.2013.018. PMID 23894860
  • Paulus WJ. H2FPEF Score: At Last, a Properly Validated Diagnostic Algorithm for Heart Failure With Preserved Ejection Fraction. Circulation. 2018 Aug 28;138(9):871-873. doi: 10.1161/CIRCULATIONAHA.118.035711. No abstract available. PMID 30354456
  • Pfeffer MA, Shah AM, Borlaug BA. Heart Failure With Preserved Ejection Fraction In Perspective. Circ Res. 2019 May 24;124(11):1598-1617. doi: 10.1161/CIRCRESAHA.119.313572. PMID 31120821
  • Papadimitriou L, Georgiopoulou VV, Kort S, Butler J, Kalogeropoulos AP. Echocardiography in Acute Heart Failure: Current Perspectives. J Card Fail. 2016 Jan;22(1):82-94. doi: 10.1016/j.cardfail.2015.08.001. Epub 2015 Aug 13. PMID 26277267
  • Fathy S, Hasanin AM, Raafat M, Mostafa MMA, Fetouh AM, Elsayed M, Badr EM, Kamal HM, Fouad AZ. Thoracic fluid content: a novel parameter for predicting failed weaning from mechanical ventilation. J Intensive Care. 2020 Mar 5;8:20. doi: 10.1186/s40560-020-00439-2. eCollection 2020. PMID 32161651
  • Vahedian-Azimi A, Gohari-Moghadam K, Rahimi-Bashar F, Samim A, Khoshfetrat M, Mohammadi SM, de Souza LC, Mahmoodpoor A. New integrated weaning indices from mechanical ventilation: A derivation-validation observational multicenter study. Front Med (Lausanne). 2022 Jul 22;9:830974. doi: 10.3389/fmed.2022.830974. eCollection 2022. PMID 35935785
  • Schmidt GA, Girard TD, Kress JP, Morris PE, Ouellette DR, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Patel S, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Wilson KC, Truwit JD. Liberation From Mechanical Ventilation in Critically Ill Adults: Executive Summary of an Official American College of Chest Physicians/American Thorac PMID 27818329

Идентификаторы

NCT: NCT07109206 · KarimPhD1

Первоисточники (государственные реестры)

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