BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units (BELLRICU)
2026年6月12日 更新者:Mercè Gasa Galmes、Hospital Universitari de Bellvitge
BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units. Improvement of Risk Stratification, Mortality Prediction and clínical Decision-making (UCRI-CAT Team).
A respiratory intermediate care unit (RICU) is a monitoring and treatment area of respiratory patients who do not required admission to intensive care unit (ICU) but due to complexity, they could not be managed in conventional ward.
Aim: To investigate those patients that could better benefit from RICU stay.
Hypothesis: a comprehensive and integrative knowledge of all factors that intervene during the RICU admission allow determining probability of survival.
Primary outcome: 1.
To construct a predictive model of mortality at 30-days after RICU admission for patients admitted to the coordinator RICU based on standard biostatistics: The BELLRICU Model.
Secondary outcomes: 2.1.
To validate the model in another cohort of patients admitted at the same RICU.
2.2.
To validate the model in an external cohort (patients admitted at the rest of Catalan active RICUs at the time of the study).
2.3.
To compare the predictive capacity of the BELLRICU model with other previous validated scales but in ICU setting.
2. 4. To explore a new predictive model using artificial intelligence (AI) techniques.
2.4.
To design a quick app to implement the BELLRICU model.
Methodology: Longitudinal prospective study (3 years), recording variables at baseline, at RICU admission and 30-days follow-up.
During the first two years, variables will be collected from the coordinator RICU to construct the BELLRICU model, being "mortality after 30-day of RICU admission" the dependent varialbe and using regression of cox proportional risks analysis.
During the third year of the study, the BELLRICU model will be applicated to the rest of the participants RICUs in order to validate the model.
Further, the predictive capacity of the BELLRICU model will be compared with the predictive capacity of previous validated scales in ICU setting and with a exploratory model using AI from BELLRICU data base.
研究概览
地位
尚未招聘
研究类型
观察性的
注册 (估计的)
624
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Mercè M GASA, Mercè, Respiratory Physician
- 电话号码:2758 034+932607685
- 邮箱:mgasa@bellvitgehospital.cat
研究联系人备份
- 姓名:Marc M PAREDES, Marc, Respiratory Physician
- 电话号码:2042 034+932607685
- 邮箱:mparedesi@bellvitgehospital.cat
学习地点
-
-
Barcelona
-
L'Hospitalet de Llobregat、Barcelona、西班牙、08907
- Respiratory Department. Hospital Universitari de Bellvitge
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Study design: prospective longitudinal multi-center study
Study Setting:
- Model construction phase at the coordinator IRCU with 8-bed capacity (extendable to 12-bed capacity from December to march, both included). Six single and 3 double rooms. Centralized monitoring. Non-invasive respiratory suport equipment for each patient. Portable echography and bronchoscopy. Transcutaneous capnography and gasometer inside IRCU. Nurse: patient ratio of 1:4. Physiotherapist: patient ratio of 1:8-12. 24-h medical assistance: two respiratory physicians on call.
- Model external validation phase at the rest of the participating IRCUs having similar services and medical complexity that the coordinator IRCU
描述
Inclusion Criteria:
- Acute or acute-on-chronic respiratory failure requiring non-invasive respiratory suport (NIRS) (Non-invasive ventilation or high flow nasal cannulae)
- Neuromuscular patients requiring tracheostomy and ventilation invasive adaptation
- Life-treating hemoptysis requiring emergent or urgent bronchial embolization (<24 hours)
- 4. Pulmonary embolism of high-intermediate risk requiring monitoring during first 24-48h of hospital admission on anticoagulation
- Patients derived from Intensive care unit (ICU) requiring intermediate Medical step before transferred safely to conventional ward (complex respiratory weaning from invasive ventilation, high-dependency nurse cures due to limiting post-critical myopathy
- Patients with thoracic cancer (onset or complication) of vital risk (major hemoptysis, massive pleural effusion, pericardial effusion on pre or cardiac arrest, pneumonitis related to oncological treatment with severe acute respiratory failure requiring NIRS, cava vein syndrome requiring emergent prothesis, etc...)
- Respiratory complications after a complex interventional bronchoscopy requiring NIRS and/or strict monitoring: after significant bleeding, bronchial laceration, severe bronchospasm, non-controlled arrhythmia
- Respiratory or/and cardiac intercurrent instability in a patient initially admitted to respiratory conventional ward.
Exclusion Criteria:
- Patient's express negative to participate in the study
- Patient already included in other simultaneous and competitive study
- Patient cognitive deterioration that unable him to understand the study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
30d -IRCU admission Mortality
大体时间:day 30 after IRCU admission
|
Monitoring and assessment mortality at 30-day after IRCU admission
|
day 30 after IRCU admission
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
30d -hospital discharge Mortality
大体时间:day 30 after hospital discharge
|
Monitoring and assessment mortality 30 day after hospital discharge
|
day 30 after hospital discharge
|
|
30d-hospital readmission rate
大体时间:day 30 after hospital discharge
|
Monitoring and assessment hospital readmission 30 day after hospital discharge
|
day 30 after hospital discharge
|
|
30d-urgent medical consultation rate
大体时间:day 30 after hospital discharge
|
Monitoring and assessment urgent Medical consultation 30 day after hospital discharge
|
day 30 after hospital discharge
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅:Salud S SANTOS, Head Respiratory Departm. HUB、Respiratory Department. Hospital Universitari de Bellvitge
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月10日
初级完成 (估计的)
2026年7月10日
研究完成 (估计的)
2029年5月30日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月9日
首次发布 (实际的)
2026年6月12日
研究记录更新
最后更新发布 (实际的)
2026年6月16日
上次提交的符合 QC 标准的更新
2026年6月12日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- PR238/24
- RP-BRN-SOCAP-FUCAP Grant 2024 (其他赠款/资助编号:AJUT A PROJECTES DE RECERCA FUNDACIÓ RAMON PLA-BRN-SOCAP-FUCAP 2024)
- SOCAP Grant 2025 (其他赠款/资助编号:Beca SOCAP Tema Lliure 2025)
- SEPAR Grant 2025 (其他赠款/资助编号:Beca SEPAR AYUDAS A LA INVESTIGACIÓN 2025. CATEGORIA: INVESTIGADOR NOVEL)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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