Auscultation of Heart and Lungs
Conditions
Keywords
HALD - Heart and Lung Diagnostic Vest
Brief summary
The goal of this observational study is to learn whether the HALD investigational device can accurately record heart, and lung sounds during a routine cardiology clinic visit. The main question aims to answer: Can the HALD device capture heart and lung sounds in different positions and during deep breaths, and do these recordings match the sounds assessed by the investigator during a physical exam? Participants will have a clinical assessment performed by the investigator as per clinic standard of care. After which, the HALD device vest will be applied to the chest of the participant , and heart and lung sounds will be recorded in a series of positions. The recordings will be transferred automatically to a computer and will later be listened to and assessed for accuracy. The information collected will be used for research purposes to help understand how the device vest may be used in the future.
Detailed description
This study is looking at how well the HALD device can record heart and lung sounds during a routine cardiology clinic visit. All participants will have a required clinic exam and ECG performed. Participants who qualify and agree to participate will put on a T-shirt and wear the HALD vest while heart and lung sounds are recorded in several positions, including lying down and sitting, with normal and deep breaths. The recorded sounds will later be compared to what the investigator heard during the exam to check for validity and accuracy. All recordings are saved securely and will be used to help researchers understand how the device could support heart and lung assessments in the future.
Interventions
None listed
Sponsors
SonoHL
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Male or Female 2. Age ≥18 years old 3. Documented history of valvular heart disease, heart failure, pericarditis, coronary artery disease or other conditions with abnormal clinical cardiopulmonary assessment as well as control participants without abnormal physical examinations for a total of 60 participants. 4. Must have had an echocardiogram performed within 12 months of enrollment or have a scheduled echocardiogram appointment expected within the next 12 months. 5. Able and willing to provide written informed consent for study participation and able to comply with the required testing
Exclusion criteria
1. \<18 years of age 2. Females pregnant, or lactating mothers 3. Participant with implantable electronic devices such as pacemakers or implantable cardioverter-defibrillator (ICD) 4. Participant has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The secondary objection is validity and accuracy Between HALD Vest Audio Recordings and Clinical Auscultation Findings | From initiation of the first vest recording position to the end of the 4-minute recording period. | The number of participants recorded heart and lung sounds from the HALD vest that match the clinical cardiologist auscultation findings as evaluated by a blinded cardiologists interpretations |
| Feasibility of HALD Vest Use: Outcome Measure: Feasibility of applying the HALD vest in a clinical setting, including ease of donning, participant comfort, workflow integration, and successful acquisition of heart and lung audio recordings. | From the time of the applying the vest to the participant to the end of the 4-minute recording period. | 1\. Percentage of participants who rated putting on the vest (with CRC assistance) as easy on a 5-point Likert scale (0 = very easy to 4 = very difficult). |
| To assess participant overall physical comfort while wearing the vest in the varying recording positions. | From initiation of the first vest recording position to the end of the 4-minute recording period. | Percentage of participants rating comfort while wearing the vest on a 5-point Likert scale (1 = very comfortable to 5 = very uncomfortable). |
| Measure the degree of difficulty for the research team to perform tasks required of the HALD vest device ( fitting the vest on the participant, positioning for recordings, obtaining recordings and data entry in computer ) | From the time of the applying the vest to the participant to the end of the 4-minute recording period. | Percentage of CRCs rating the overall HALD vest workflow (fitting the vest, positioning the participant, obtaining recordings, and entering data into the SonoHL system) on a 5-point Likert scale from very easy to very difficult. |
Countries
Canada
Contacts
CONTACTMark Liszkowski, MD, Cardiologist
PRINCIPAL_INVESTIGATORLiskowski, MD, Cardiologist
Glen Centre Specilaized Medicine Clinic
Outcome results
None listed