COPDACCUMEN-POCUSNCT05423652
Aiding COPD and CHF Ultrasound-guided Management Through ENhanced Point Of Care UltraSound
A study testing Lung point of care ultrasound and PRESUNA software in people with COPD and CHF, run by Michelle Grinman at 1 site in Canada.
Trial summary
Single-center, two-arm, parallel, randomized controlled trial comparing enhanced daily assessments for patients with COPD and/or CHF using point of care ultrasound with PRESUNA software (POCUS-PRESUNA) versus standard care provided by home-based acute care through a tertiary acute care medical teaching hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Lung point of care ultrasound and PRESUNA software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 16 Oct 2023to 30 Sep 2025
- Phase
- Interventional
- 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
Patient Inclusion Criteria:
- 18 years of age or older
- Has a provincial health care number
- Functionally safe to receive HH care or have sufficient caregiving to support them at home
- Stable enough to be cared for at home - stable vital signs and requiring no more than 2 visits per day
- Able and willing to follow a management plan
- Provides consent to receive care on HH
- Diagnosis of CHF and/or COPD that requires HH care
- No painful/broken ribs that could be affected by pressure applied when performing lung POCUS
Patient Exclusion Criteria:
- Not eligible for HH care
- New unstable rib fractures
- Prior history of allergy to ultrasound gel
- Participant refusal to participate in research study
Provider inclusion criteria
- Attending clinician on the home hospital program within the next 3-6 months
- Provides informed consent to participate in the study, including necessary training for the use of POCUS and/or PRESUNA
Provider exclusion criteria
- Not a home hospital clinician
- Refuses to consent for the study / training.
Trial locations and contacts
1 site in 1 country.
About this study
Single-center, two-arm, parallel, randomized controlled trial comparing enhanced daily assessments for patients with COPD and/or CHF using point of care ultrasound with PRESUNA software (POCUS-PRESUNA) versus standard care provided by home-based acute care through a tertiary acute care medical teaching hospital. The objectives are to evaluate POCUS-PRESUNA on improving patient experience, provider experience, improve healthcare utilization/costs, and to test the feasibility of incorporating longitudinal POCUS assessments in home-based acute care via remotely acquired images by non-physicians.
Read the detailed description
PRESUNA, a new medical software platform that supports clinicians in optimizing their use of POCUS for CHF and COPD patients in the community, is designed to enhance clinical decision-making and long-term monitoring of patients with CHF and COPD. The aim is to more precisely identify changes in the lungs in order to proactively treat exacerbations and confirm treatment responses. It will also enable practitioners to share information from each scan visually and in a standard format in order to track changes longitudinally. This is expected to reduce potentially avoidable hospitalizations and increase patient quality of life in the community.
This study will implement the use of POCUS enhanced by PRESUNA software in the clinical practice of clinicians on a home hospital (HH) program at a tertiary teaching hospital in Calgary, Alberta. On this home hospital, patients are seen and examined either by home visiting community paramedics who consult with the physician, or in-person by physicians in the home hospital clinic space when expedited diagnostic imaging or investigations are required.
Objective:
To perform a randomized control trial comparing patients with COPD and/or CHF admitted to the HH who will undergo usual care versus usual care enhanced with POCUS and PRESUNA.
Methods:
- Practitioner Recruitment Home hospital clinicians will be provided information about this study in order to obtain informed consent for participation in the study. Physicians who are already POCUS experts will provide informed consent to undergo training on how to use PRESUNA software and to incorporate POCUS into their home hospital care for intervention study patients. Non-POCUS expert clinicians (community paramedics, some of the physicians and nurses) will provide informed consent to undergo group POCUS training and subsequent individual training sessions in order to enable them to become proficient at using POCUS. They will also consent to being trained on how to use PRESUNA software, as well as incorporating POCUS and PRESUNA into their home hospital care for intervention arm patients.
- Patient Recruitment Patients admitted to HH with CHF and/or COPD will be approached to participate in the research study by the Nurse Navigator or Research Assistant. Those that provide informed consent will be randomized (1:1) to the intervention (POCUS-PRESUNA enhanced HH care) versus control group (usual HH care).
- Being tested
- Lung point of care ultrasound, PRESUNA software
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung point of care ultrasoundDevice
Also called POCUS
Point of care ultrasound of the lungs will be performed to enhance physical assessments as needed to make clinical decisions for patients with CHF, COPD and/or pneumonia. The majority of images will be acquired and uploaded to a web-based portal by community paramedics in patients' homes and interpreted remotely by hospital-based physicians on call for the home hospital.
PRESUNA softwareOther
PRESUNA is a new medical software that enables clinicians to summarize POCUS findings and document them on a platform that provides a visual summary of findings over time. PRESUNA also provides POCUS educators and learners to see the learners' progress over time in terms of the accuracy of their assessments when compared to POCUS experts providing longitudinal mentorship.
| Study group | Role | What they receive |
|---|---|---|
| POCUS-PRESUNA | Experimental | Daily home hospital care will be enhanced by lung POCUS acquired remotely by community paramedics or in-person by physicians, and interpreted by physicians. They will then document their findings on PRESUNA to obtain a longitudinal record that enables monitoring of trends to support clinical decision-making. Receives: Device: Lung point of care ultrasound; Other: PRESUNA software |
| Standard Care | No intervention | Standard home hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Length of stay for index Home Hospital admission
Measured: From the date of admission to discharge from the index admission, assessed up to 1 year
Secondary outcomes (21)
Patient outcome - Time to resolution of infection
return to baseline oxygen saturation and normalization of white blood cell count
Measured: Assessed up to 24 months after infection identified
Patient outcome - time to decongestion
absence of crackles and baseline oxygen saturation on lung examination
Measured: Assessed up to one year after congestion identified
Patient outcome - rate of change in NT-BNP
Difference between NT-BNP on admission and at time of decongestion over total number of days
Measured: Change from admission to when decongestion occurred, assessed up to 12 months
Patient outcome - Admission to facility living
Proportion of patients in each study arm that required admission to facility living (eg: long-term care, supportive living) after their index admission
Measured: From date and time of discharge from index admission, assessed up to 12 months
Patient outcome - Escalation of care
Incidence rate ratio for frequency with which patients are transferred back to the bricks and mortar hospital from the home hospital.
Measured: From date of randomization until the patient is discharged from the index admission (assessed up to 12 months).
Patient outcome - Adverse events
Frequency and severity of adverse events (venous thromboembolism, new infections, falls, delirium)
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first until the patient is discharged from the hospital (assessed up to 12 months).
Patient outcome - Mortality
Date and cause of mortality of occurrence of mortality
Measured: From date of randomization until the date of death, assessed up to 12 months
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Mobility
The ability to mobilize is rated by patients on a scale from 1-5 (1= no problems, 2= slight problems, 3= moderate problems, 4= Severe problems, 5= Unable to perform activity)
Measured: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Activities of daily living
Ability to perform activities of daily living rated by patients from 1-5 (1= no problems, 2= slight problems, 3= moderate problems, 4= Severe problems, 5= Unable to perform activity)
Measured: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Pain and discomfort
The intensity of pain or discomfort is rated by patients from 1 to 5 (1=none, 2= slight , 3= moderate , 4=severe, 5=extreme).
Measured: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Self care
Ability to perform self-care rated from 1= no problems, 2= slight problems, 3= moderate problems, 4= Severe problems, 5= Unable to perform activity
Measured: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Anxiety and Depression
Patients rate whether they feel anxious or depressed from 1-5 (1=no, 2= slightly, 3= moderately, 4=severely, 5=extremely).
Measured: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Index Score
The index score is computed using the EQ-5D calculator that uses the scores of the individual dimensions (mobility, self-care, activities of daily living, pain and discomfort, anxiety and depression); Scores range between 5-25 with higher scores indicating a worse outcome
Measured: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) Visual Analogue Scale (EQ-VAS)
Participant asked to rate both verbally and visually "where [they] would put [their] health today" on a scale from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine)
Measured: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Patient experience
Survey measuring experience with clinical care and various technologies employed by the Home Hospital (digital remote patient monitoring, videoconferencing, as well as POCUS for the intervention arm). This survey was developed by the study team. Responses to questions were either, "yes", "yes, to some extent", "no", and "unsure".
Measured: Upon discharge from the Home Hospital (up to 7 business days post-discharge)
Provider experience
Surveys including experience providing care for patients on each study arm and experience with various technologies employed in the home hospital program (digital remote patient monitoring, videoconferencing, as well as POCUS and PRESUNA for the intervention arm). This survey was developed by the study team. Responses were on a Likert scale, which included "strongly disagree", "disagree", "neither agree/nor disagree", "agree" and "strongly agree"
Measured: Within 1 week of being on the Hospital at Home service
Healthcare utilization cost - Diagnostic testing
Cost of Diagnostic testing
Measured: Between the date and time of hospital admission to up to 3 months post-discharge
Healthcare utilization - Incidence rate ratio of acute care days pre/during/post
Incidence rate ratio of acute care days in the bricks and mortar hospital 90 days pre-randomization, during the index admission after randomization, and 90 days post discharge from index admission
Measured: 90 days before randomization until 90 days after index admission (assessed up to 15 months)
Healthcare utilization - Incidence rate ratio of ED/Urgent Care visits pre/during/post
Incidence rate ratio of ED and urgent care visits- 90 days pre-randomization, during the index admission after randomization, and 90 days post discharge from index admission
Measured: 90 days before, during and 90 days after index admission
Cost analysis
Incremental effectiveness ratio for the index admission
Measured: From date of admission until the date of discharge from the index admission, assessed up to 12 months").
Cost analysis
Incremental effectiveness ratio for healthcare utilization post-discharge
Measured: From date of discharge from index admission, assessed up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start16 Oct 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Grinman
- Sponsor type
- University, hospital or other
- Collaborators
- PRESUNA, Institute of Health Economics, Canada, Alberta Boehringer Ingelheim Collaboration
- Responsible party
- Sponsor-investigator, Michelle Grinman, University of Calgary
- Investigators
- Michelle Grinman, MD FRCPC MPH, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423652
- Sponsor's protocol ID
- REB22-0434
- Acronym
- ACCUMEN-POCUS
- Status last verified
- Mar 2025
- First submitted
- 5 May 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grinman MN, Nakhla P, Reid S, Moon D, Dehghan Noudeh N, Olaosebikan O, Ip ACY, Saunders S, Kozicky R, Conly J, Kirkpatrick AW, Round J, Ma IWY, Pascoe S, Altabbaa G. Aiding Chronic Obstructive Pulmonary Disease and Congestive Heart Failure Ultrasound-Guided Management Through Enhanced Point-of-Care Ultrasound (ACCUMEN-POCUS): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 23;14:e76186. doi: 10.2196/76186.
PubMed 40987446
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aiding COPD and CHF Ultrasound-guided Management Through ENhanced Point Of Care UltraSound
- ClinicalTrials.gov ID
- NCT05423652
- Acronym / sponsor ID
- ACCUMEN-POCUS / REB22-0434
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Michelle GrinmanUniversity, hospital or other
- Collaborators
- PRESUNA, Institute of Health Economics, Canada, Alberta Boehringer Ingelheim Collaboration
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 21 Jun 2022 (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.
Single-center, two-arm, parallel, randomized controlled trial comparing enhanced daily assessments for patients with COPD and/or CHF using point of care ultrasound with PRESUNA software (POCUS-PRESUNA) versus standard care provided by home-based acute care through a tertiary acute care medical teaching hospital. The objectives are to evaluate POCUS-PRESUNA on improving patient experience, provider experience, improve healthcare utilization/costs, and to test the feasibility of incorporating longitudinal POCUS assessments in home-based acute care via remotely acquired images by non-physicians.
Detailed description
PRESUNA, a new medical software platform that supports clinicians in optimizing their use of POCUS for CHF and COPD patients in the community, is designed to enhance clinical decision-making and long-term monitoring of patients with CHF and COPD. The aim is to more precisely identify changes in the lungs in order to proactively treat exacerbations and confirm treatment responses. It will also enable practitioners to share information from each scan visually and in a standard format in order to track changes longitudinally. This is expected to reduce potentially avoidable hospitalizations and increase patient quality of life in the community.
This study will implement the use of POCUS enhanced by PRESUNA software in the clinical practice of clinicians on a home hospital (HH) program at a tertiary teaching hospital in Calgary, Alberta. On this home hospital, patients are seen and examined either by home visiting community paramedics who consult with the physician, or in-person by physicians in the home hospital clinic space when expedited diagnostic imaging or investigations are required.
Objective:
To perform a randomized control trial comparing patients with COPD and/or CHF admitted to the HH who will undergo usual care versus usual care enhanced with POCUS and PRESUNA.
Methods:
- Practitioner Recruitment Home hospital clinicians will be provided information about this study in order to obtain informed consent for participation in the study. Physicians who are already POCUS experts will provide informed consent to undergo training on how to use PRESUNA software and to incorporate POCUS into their home hospital care for intervention study patients. Non-POCUS expert clinicians (community paramedics, some of the physicians and nurses) will provide informed consent to undergo group POCUS training and subsequent individual training sessions in order to enable them to become proficient at using POCUS. They will also consent to being trained on how to use PRESUNA software, as well as incorporating POCUS and PRESUNA into their home hospital care for intervention arm patients.
- Patient Recruitment Patients admitted to HH with CHF and/or COPD will be approached to participate in the research study by the Nurse Navigator or Research Assistant. Those that provide informed consent will be randomized (1:1) to the intervention (POCUS-PRESUNA enhanced HH care) versus control group (usual HH care).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POCUS-PRESUNA | Experimental | Device: Lung point of care ultrasound, Other: PRESUNA softwareDaily home hospital care will be enhanced by lung POCUS acquired remotely by community paramedics or in-person by physicians, and interpreted by physicians. They will then document their findings on PRESUNA to obtain a longitudinal record that enables monitoring of trends to support clinical decision-making. |
| Standard Care | No intervention | –Standard home hospital care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung point of care ultrasoundAlso: POCUSPoint of care ultrasound of the lungs will be performed to enhance physical assessments as needed to make clinical decisions for patients with CHF, COPD and/or pneumonia. The majority of images will be acquired and uploaded to a web-based portal by community paramedics in patients' homes and interpreted remotely by hospital-based physicians on call for the home hospital. | Device | POCUS-PRESUNA |
| PRESUNA softwarePRESUNA is a new medical software that enables clinicians to summarize POCUS findings and document them on a platform that provides a visual summary of findings over time. PRESUNA also provides POCUS educators and learners to see the learners' progress over time in terms of the accuracy of their assessments when compared to POCUS experts providing longitudinal mentorship. | Other | POCUS-PRESUNA |
Primary outcome
Length of stay
Time frame: From the date of admission to discharge from the index admission, assessed up to 1 year
Length of stay for index Home Hospital admission
21 secondary outcomes
Patient outcome - Time to resolution of infection
Time frame: Assessed up to 24 months after infection identified
Patient outcome - time to decongestion
Time frame: Assessed up to one year after congestion identified
Patient outcome - rate of change in NT-BNP
Time frame: Change from admission to when decongestion occurred, assessed up to 12 months
Patient outcome - Admission to facility living
Time frame: From date and time of discharge from index admission, assessed up to 12 months
Patient outcome - Escalation of care
Time frame: From date of randomization until the patient is discharged from the index admission (assessed up to 12 months).
Patient outcome - Adverse events
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first until the patient is discharged from the hospital (assessed up to 12 months).
Patient outcome - Mortality
Time frame: From date of randomization until the date of death, assessed up to 12 months
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Mobility
Time frame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Activities of daily living
Time frame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Pain and discomfort
Time frame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Self care
Time frame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Anxiety and Depression
Time frame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Index Score
Time frame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) Visual Analogue Scale (EQ-VAS)
Time frame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
Patient experience
Time frame: Upon discharge from the Home Hospital (up to 7 business days post-discharge)
Provider experience
Time frame: Within 1 week of being on the Hospital at Home service
Healthcare utilization cost - Diagnostic testing
Time frame: Between the date and time of hospital admission to up to 3 months post-discharge
Healthcare utilization - Incidence rate ratio of acute care days pre/during/post
Time frame: 90 days before randomization until 90 days after index admission (assessed up to 15 months)
Healthcare utilization - Incidence rate ratio of ED/Urgent Care visits pre/during/post
Time frame: 90 days before, during and 90 days after index admission
Cost analysis
Time frame: From date of admission until the date of discharge from the index admission, assessed up to 12 months").
Cost analysis
Time frame: From date of discharge from index admission, assessed up to 90 days.
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 2 Apr 2025.
- Derived from this study: PubMed 40987446Grinman MN, Nakhla P, Reid S, Moon D, Dehghan Noudeh N, Olaosebikan O, Ip ACY, Saunders S, Kozicky R, Conly J, Kirkpatrick AW, Round J, Ma IWY, Pascoe S, Altabbaa G. Aiding Chronic Obstructive Pulmonary Disease and Congestive Heart Failure Ultrasound-Guided Management Through Enhanced Point-of-Care Ultrasound (ACCUMEN-POCUS): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 23;14:e76186. doi: 10.2196/76186.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michelle Grinman, MD FRCPC MPH principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung point of care ultrasound and PRESUNA software in people with COPD and CHF, run by Michelle Grinman at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: From the date of admission to discharge from the index admission, assessed up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05423652, which also lists 1 linked publication.
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 2 Apr 2025.