Prediction of Postoperative Pulmonary Complications in Thoracic Surgery
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Evaluation of prognostic performance of a defined score using a machine learning method (STABL: Stability Selection) integrating immune data (cytometric and proteomic).
- Кому может быть актуально
- Состояния в реестре: Postoperative Pulmonary Complications (PPCs). Базовые параметры: 18 лет — 99 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
- Франция
- 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
Prediction of Postoperative Pulmonary Complications in Thoracic Surgery: an Immuno-inflammatory Approach
Обзор
Lung cancer is a common disease, and its treatment is lobectomy or pulmonary segmentectomy. In France, approximately 8,000 patients undergo this procedure each year, but it remains associated with significant Postoperative Pulmonary Complications (PPC). This surgical trauma triggers a multicellular and orchestrated immune response, necessary for defense against pathogens, as well as for inflammatory resolution and wound healing. Preoperative single-cell analysis of the patient's immune system is therefore a promising strategy for identifying biomarkers of postoperative pulmonary complications (PPC). Brice Gaudilliere's laboratory at Stanford University, in collaboration with the Paris-based startup Surge, has developed and patented a multivariate model integrating mass cytometry data, proteomic analyses, and clinical data collected before surgery to accurately predict surgical site complications after major abdominal surgery. However, no study has yet explored the identification of inflammatory biomarkers predictive of PPC after thoracic surgery.
Подробное описание
The issue of postoperative pulmonary complications following major lung resection (such as lobectomy or segmentectomy) is a central topic in anesthesia and thoracic surgery. Postoperative morbidity and mortality after this type of surgery have drastically decreased in recent years with advances in anesthesia and resuscitation, as well as minimally invasive surgery, but remain high compared to other types of surgery, particularly due to postoperative pneumonia. The etiology of postoperative pneumonia is multifactorial (atelectasis, postoperative ventilation, inadequate analgesia), but the patient's immune system plays a predominant role in each individual case. Therefore, identifying inflammatory biomarkers predictive of postoperative pulmonary complications in a given patient could optimize their management and reduce the risk of postoperative pulmonary cancer (PPC). The objective of this study is to identify preoperative inflammatory biomarkers predictive of PPC after major lung resection. It will use machine learning methods specific to these data to define an immune signature of PPC. This immune signature will be validated using standard analytical techniques to facilitate the clinical translation of a diagnostic test.
Вмешательства
- Диагностический тест Evaluation of prognostic performance of a defined score using a machine learning method (STABL: Stability Selection) integrating immune data (cytometric and proteomic)
Determination of the area under the curve (AUC) Receiver Operating Curve (ROC) for predicting complications calculated from the score obtained by the machine learning method and the occurrence of at least one major pulmonary complication among the following in the first 7 postoperative days: postoperative pneumonia, pleural effusion, postoperative atelectasis, pneumothorax, bronchospasm and acute respiratory distress syndrome.
Первичные конечные точки
- Evaluation of the prognostic performance of a score for screening patients at risk of postoperative pulmonary complications (PPC) [Срок оценки: Evaluation of the prognostic performance of a defined score using a machine learning method (STABL: Stability Selection) integrating preoperative immune (cytometric and proteomic) and clinical data within 7 postoperative days of a major lung resection]
Вторичные конечные точки (12)
- Evaluation of the incidence of pulmonary complications [Срок оценки: 30 days]
- Evaluation of the correlation between the prognostic score defined using a machine learning method and the length of hospital stay [Срок оценки: 3 months]
- Evaluation of the correlation between the prognostic score defined using a machine learning method and the number of reintubations recorded [Срок оценки: 30 days]
- Evaluation of the correlation between the prognostic score defined using a machine learning method and the Number of unplanned hospitalizations in intensive care recorded [Срок оценки: 30 days]
- Evaluation of the correlation between the prognostic score defined using a machine learning method and the Preoperative anxiety score assessed [Срок оценки: 48 hours]
- Evaluation of the correlation between the prognostic score defined using a machine learning method and the Preoperative anxiety score assessed [Срок оценки: 48 hours]
- Evaluation of the correlation between the prognostic score defined using a machine learning method and The cost of care [Срок оценки: 3 months]
- Evaluation of the prognostic performance of the score calculated by the machine learning method on Post-operative Pulmonary Complications (PPC) assessed by the Melbourne composite score (Melbourne Group Scale (MGS) >=4) [Срок оценки: 7 days]
- Evaluation of the prognostic performance of the score calculated by the machine learning method on the severity of postpartum bleeding (PPB) [Срок оценки: 30 days]
- Evaluation of the prognostic performance of the score calculated by the machine learning method on Postoperative mortality assessed at 30 days [Срок оценки: 30 days]
- Evaluation of the prognostic performance of the score calculated by the machine learning method on Postoperative mortality assessed at 90 days [Срок оценки: 90 days]
- Evaluation of the prognostic performance of the score calculated by the machine learning method on Pre- and postoperative pain [Срок оценки: 90 days]
Критерии участия
Критерии включения
- Age ≥ 18 years
- ASA score ≤ 3
- Patients undergoing scheduled video-assisted or robot-assisted lobectomy, bilobectomy, or segmentectomy.
- Patients who have read and understood the information letter and do not object to the research.
- For women of childbearing age (non-sterile): effective contraception
- Menopausal (non-medically induced amenorrhea for at least 12 months)
- Patients covered by a social security scheme
Критерии исключения
- Minor patients
- Surgery scheduled for a Friday
- Patients undergoing a pneumonectomy
- Pregnant or breastfeeding women
- Patients deprived of their liberty by an administrative or judicial decision, as well as those under legal protection, guardianship, or curatorship
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Франция · 1 центр
- Service de Anesthésie-Réanimation Médecine périopératoire CHU de Rouen — Rouen
Идентификаторы
NCT: NCT07359885 · 2024/0307/HP · 2025-A01699-40