Aiding COPD and CHF Ultrasound-guided Management Through ENhanced Point Of Care UltraSound

NCT05423652 | Active Not Recruiting

• 1 other identifier: REB22-0434
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COPD; CHF; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Length of stay for index Home Hospital admission

  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

  Assessed up to 24 months after infection identified

• Patient outcome - time to decongestion

  Assessed up to one year after congestion identified

• Patient outcome - rate of change in NT-BNP

  Change from admission to when decongestion occurred, assessed up to 12 months

• Patient outcome - Admission to facility living

  From date and time of discharge from index admission, assessed up to 12 months

• Patient outcome - Escalation of care

  From date of randomization until the patient is discharged from the index admission (assessed up to 12 months).

Study Arms (2)

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.

Device: Lung point of care ultrasound; Other: PRESUNA software

Standard Care

NO INTERVENTION

Standard home hospital care

Interventions

Lung point of care ultrasound DEVICE

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.

Also known as: POCUS

POCUS-PRESUNA

PRESUNA software OTHER

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.

POCUS-PRESUNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not eligible for HH care
• New unstable rib fractures
• Prior history of allergy to ultrasound gel
• Participant refusal to participate in research study
• 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
• Not a home hospital clinician
• Refuses to consent for the study / training.

Sponsors & Collaborators

• Michelle Grinman: lead
• PRESUNA: collaborator
• Institute of Health Economics, Canada: collaborator
• Alberta Boehringer Ingelheim Collaboration: collaborator

Study Sites (1)

Rockyview General Hospital

Calgary, Canada

Location

Related Publications (1)

• 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.

  PMID: 40987446 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pneumonia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections

Study Officials

• Michelle Grinman, MD FRCPC MPH

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: June 21, 2022
• Study Start: October 16, 2023
• Primary Completion: March 31, 2025
• Study Completion: September 30, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)