Acute Respiratory Failure (ARF)BELLRICUNCT07644637
BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units
An observational study of Acute Respiratory Failure (ARF) and Intermediate Respiratory Care Unit, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure (ARF), Intermediate Respiratory Care Unit, Respiratory Precision Medicine
- How many people
- 624 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2026to 30 May 2029
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mercè M GASA, Mercè, Respiratory Physician contact
Marc M PAREDES, Marc, Respiratory Physician contact
Spain1 site
Respiratory Department. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: 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.
- Conditions
- Acute Respiratory Failure (ARF), Intermediate Respiratory Care Unit, Respiratory Precision Medicine, Mortality Prediction, Stratification Risk
- Keywords
- Acute Respiratory Failure, Non-invasive Respiratory Support, Intermediate Respiratory Care Unit, Intensive Care Unit
What is being measured
The primary outcome is the main question the study is designed to answer.
30d -IRCU admission Mortality
Monitoring and assessment mortality at 30-day after IRCU admission
Measured: day 30 after IRCU admission
Secondary outcomes (3)
30d -hospital discharge Mortality
Monitoring and assessment mortality 30 day after hospital discharge
Measured: day 30 after hospital discharge
30d-hospital readmission rate
Monitoring and assessment hospital readmission 30 day after hospital discharge
Measured: day 30 after hospital discharge
30d-urgent medical consultation rate
Monitoring and assessment urgent Medical consultation 30 day after hospital discharge
Measured: day 30 after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start10 Jun 2026 (estimated)
- Primary completion10 Jul 2026 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure (ARF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 624 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mercè Gasa Galmes, Hospital Universitari de Bellvitge
- Investigators
- Salud S SANTOS, Head Respiratory Departm. HUB, Study chair, Respiratory Department. Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644637
- Sponsor's protocol ID
- PR238/24
- Other IDs
- RP-BRN-SOCAP-FUCAP Grant 2024, SOCAP Grant 2025, SEPAR Grant 2025
- Acronym
- BELLRICU
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BELLRICU PROJECT: Precision Medicine in Respiratory Intermediate Care Units. Improvement of Risk Stratification, Mortality Prediction and clínical Decision-making (UCRI-CAT Team).
- ClinicalTrials.gov ID
- NCT07644637
- Acronym / sponsor ID
- BELLRICU / PR238/24
- Conditions
- Acute Respiratory Failure (ARF), Intermediate Respiratory Care Unit, Respiratory Precision Medicine, Mortality Prediction, Stratification Risk
- Keywords
- Acute Respiratory Failure, Non-invasive Respiratory Support, Intermediate Respiratory Care Unit, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 624 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30d -IRCU admission Mortality
Time frame: day 30 after IRCU admission
Monitoring and assessment mortality at 30-day after IRCU admission
3 secondary outcomes
30d -hospital discharge Mortality
Time frame: day 30 after hospital discharge
30d-hospital readmission rate
Time frame: day 30 after hospital discharge
30d-urgent medical consultation rate
Time frame: day 30 after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mercè M GASA, Mercè, Respiratory Physician contact
Marc M PAREDES, Marc, Respiratory Physician contact
Salud S SANTOS, Head Respiratory Departm. HUB study chair
Respiratory Department. Hospital Universitari de Bellvitge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure (ARF) and Intermediate Respiratory Care Unit, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mercè M GASA, Mercè, Respiratory Physician (034+932607685 ext. 2758, mgasa@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30d -IRCU admission Mortality (time frame: day 30 after IRCU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.