About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
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
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
30d -IRCU admission Mortality
Monitoring and assessment mortality at 30-day after IRCU admission
Secondary outcomes
30d -hospital discharge Mortality
Monitoring and assessment mortality 30 day after hospital discharge
30d-hospital readmission rate
Monitoring and assessment hospital readmission 30 day after hospital discharge
30d-urgent medical consultation rate
Monitoring and assessment urgent Medical consultation 30 day after hospital discharge
Sponsors and contacts
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