Portable chest device to detect lung fluid in people with heart failure
A Portable Thoracic Impedance Device for Detecting Pulmonary Congestion in Heart Failure Patients
This project tests a small chest bioimpedance device to see if it can detect early lung fluid buildup in adults with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06604468 on ClinicalTrials.gov |
What this trial studies
This prospective, cross-sectional observational study compares a portable thoracic bioimpedance tomography (TBIT) device with portable lung ultrasound, CT imaging, blood biomarkers, and symptom questionnaires to measure pulmonary congestion. Adults are recruited during hospital admissions or outpatient visits at heart failure and nephrology clinics at CHUM and undergo on-site TBIT measurements, lung ultrasound B-line scoring, CT-derived thoracic water content when available, and NT-proBNP testing. Correlations will be analyzed using methods such as Spearman correlation and mixed-effects models, and study procedures are observational so patient treatment is not changed based on TBIT results. The aim is to validate TBIT as a non-invasive, cost-effective tool for earlier detection of lung congestion that could support outpatient management.
Who should consider this trial
Good fit: Adults aged 18 or older with a diagnosis of heart failure and a hospitalization or emergency visit for decompensated heart failure within the past 12 months who can give informed consent are ideal candidates.
Not a fit: Patients who are pregnant, have implanted thoracic electronic devices (e.g., pacemaker or defibrillator), are in intensive/coronary care, or cannot provide consent are excluded and may not benefit from this device.
Why it matters
Potential benefit: If successful, the device could allow earlier detection of pulmonary congestion outside the hospital and help guide outpatient fluid management to reduce heart failure hospitalizations.
How similar studies have performed: Prior research using thoracic bioimpedance and lung ultrasound has shown promising correlations with pulmonary congestion, but portable TBIT devices are relatively novel and require further validation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older. * Diagnosed with heart failure, defined by the following criterion: hospitalization or an emergency visit for decompensated heart failure (pulmonary edema) within the last 12 months. Exclusion Criteria: * Pregnant women at the time of eligibility evaluation. * Presence of an implanted electronic device in the thorax, such as a pacemaker or defibrillator. * Inability to provide informed consent. * Admission to intensive care or the coronary care unit.
Where this trial is running
Montreal, Quebec
- Chum — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: William Beaubien-Souligny, MD PhD
- Email: william.beaubien-souligny.med@ssss.gouv.qc.ca
- Phone: 15148908000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.