BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Universitari de Bellvitge

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

30d -IRCU admission Mortality

Monitoring and assessment mortality at 30-day after IRCU admission

Time frame
day 30 after IRCU admission

Secondary outcomes

1

30d -hospital discharge Mortality

Monitoring and assessment mortality 30 day after hospital discharge

Time frame
day 30 after hospital discharge
2

30d-hospital readmission rate

Monitoring and assessment hospital readmission 30 day after hospital discharge

Time frame
day 30 after hospital discharge
3

30d-urgent medical consultation rate

Monitoring and assessment urgent Medical consultation 30 day after hospital discharge

Time frame
day 30 after hospital discharge

Other outcomes

Sponsors and contacts

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