Enhanced Point of Care Ultrasound for COPD

(ACCUMEN-POCUS Trial)

Overseen By Michelle Grinman, MD FRCPC MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michelle Grinman

Disqualifiers: Unstable rib fractures, Allergy to gel, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage chronic obstructive pulmonary disease (COPD) and heart failure (CHF) using a special type of ultrasound at home. The researchers aim to determine if lung point-of-care ultrasound with PRESUNA software can improve patient and provider experiences and reduce healthcare costs compared to standard home care. One group will receive enhanced daily care with ultrasound assessments, while the other will receive regular home care. Suitable participants have COPD or CHF, can safely stay at home for their care, and do not have painful or broken ribs that would affect the ultrasound. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance home care for COPD and CHF patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this enhanced point of care ultrasound is safe for COPD and/or CHF patients?

Research shows that lung point-of-care ultrasound with PRESUNA software is generally well-tolerated. Studies have found this method helpful for assessing patients with breathing problems, such as COPD (chronic obstructive pulmonary disease) and CHF (congestive heart failure).

The ultrasound technique is non-invasive, using sound waves to create images of the lungs without entering the body. This makes it safe for repeated use. Reviewed studies do not mention any major side effects, suggesting it is safe for most people.

PRESUNA software helps track ultrasound results over time, aiding doctors in making better decisions without adding known risks. Overall, this approach appears to be a safe way to enhance care at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Point of Care Ultrasound (POCUS) for COPD because it offers a new way to monitor lung health directly from patients' homes. Unlike traditional treatments that rely on periodic in-person visits and imaging tests, this method uses lung ultrasounds performed by community paramedics or physicians. The results are documented using PRESUNA software, which helps track changes over time and supports better clinical decision-making. This approach could allow for more personalized and timely interventions, potentially improving outcomes for COPD patients.

What evidence suggests that this ultrasound technique is effective for COPD?

In this trial, participants will receive either enhanced care with lung point-of-care ultrasound (POCUS) and PRESUNA software or standard care. Research has shown that POCUS effectively manages conditions like COPD and CHF. Specifically, one study found that POCUS reduced hospital stays by 46% compared to standard care. POCUS also helps identify breathing problems early, enabling doctors to select the best treatment more quickly. The PRESUNA software, used in this trial, assists with these ultrasound checks by allowing doctors to track changes over time, leading to better decisions. Together, POCUS and PRESUNA aim to improve care by detecting issues sooner and reducing hospitalizations. ^{1 2 5 6 7}

Who Is on the Research Team?

Michelle Grinman, MD FRCPC MPH

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Chronic Obstructive Pulmonary Disease (COPD) or Congestive Heart Failure (CHF), who need home health care but are stable enough not to require more than two visits per day. They must be able to follow a management plan, have no allergies to ultrasound gel, and no new unstable rib fractures.

Inclusion Criteria

I can safely receive care at home or have someone to help me.

I have CHF or COPD and need home health care.

I can be cared for at home with stable vital signs and need no more than 2 visits a day.

Exclusion Criteria

I have new, unstable fractures in my ribs.

Not eligible for HH care

Prior history of allergy to ultrasound gel

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily home hospital care enhanced by lung POCUS acquired remotely by community paramedics or in-person by physicians, and interpreted by physicians using PRESUNA software

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of healthcare utilization, quality of life, and patient outcomes

Up to 6 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Lung point of care ultrasound
• PRESUNA software

Trial Overview The study compares the use of an enhanced daily lung assessment tool called POCUS-PRESUNA against standard home-based acute care in patients with COPD/CHF. It aims to see if this technology can improve patient and provider experiences, reduce healthcare costs, and test its feasibility for long-term use by non-physicians at home.

How Is the Trial Designed?

Group I: POCUS-PRESUNA Experimental Treatment 2 Interventions

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.

Group II: Standard Care Active Control 1 Intervention

Standard home hospital care

Who Is Running the Clinical Trial?

Michelle Grinman

Lead Sponsor

Trials

1

Recruited

40+

Alberta Boehringer Ingelheim Collaboration

Collaborator

Trials

2

Recruited

100+

PRESUNA

Collaborator

Trials

1

Recruited

40+

Institute of Health Economics, Canada

Collaborator

Trials

9

Recruited

3,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12504898/

Aiding Chronic Obstructive Pulmonary Disease and ... The study by Öhman et al [35] showed a 46% reduction in hospital LOS in the standard care group versus the treatment arm that used ...

2. journal.chestnet.org journal.chestnet.org/article/S0012-3692(23)03528-6/fulltext

CLINICIAN EXPERIENCES, FEASIBILITY, AND OUTCOMES ... In 5 (20%) patients with obstructive lung disease, POCUS showed a predominant A-line pattern. CONCLUSIONS: The main barrier to the use of POCUS in our clinic ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12535007/

Predictive value analysis of diaphragmatic ultrasound ... Our retrospective study thus aimed to elucidate the predictive value of diaphragmatic ultrasound evaluation, using standardized search criteria ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S095362052500233X

Point of care ultrasound: focus on evidence for a critical ... showed that lung ultrasound (LUS) had the highest positive likelihood ratio for ADHF (7.4, 95 % CI: 4.2–12.8) compared to physical examination ...

5. auntminnie.com auntminnie.com/clinical-news/ultrasound/article/15743846/lung-pocus-helps-diagnose-dyspnea-in-emergency-departments

Lung POCUS helps diagnose dyspnea in emergency ... They highlighted that lung POCUS can identify causes of acute dyspnea, improve patient flows in the emergency department, and prevent expensive ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05423652

NCT05423652 | Aiding COPD and CHF Ultrasound-guided ... 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 ...

7. sjtrem.biomedcentral.com sjtrem.biomedcentral.com/articles/10.1186/s13049-021-00872-8

Point-of-care ultrasound of the heart and lungs in patients with ... PoCUS of the lungs has proven to be a helpful tool in the assessment of patients with suspected respiratory diseases and has proven to be ...