An Observational Prospective Study to Assess the Feasibility of a Cardiorespiratory Medical Device, HALD (Heart and Lung Diagnostic) and Its Ability to Obtain Heart and Lung Sound Recordings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The secondary objection is validity and accuracy Between HALD Vest Audio Recordings and Clinical Auscultation Findings
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Age ≥18 years old
- •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.
- •Must have had an echocardiogram performed within 12 months of enrollment or have a scheduled echocardiogram appointment expected within the next 12 months.
- •Able and willing to provide written informed consent for study participation and able to comply with the required testing
排除标准
- •<18 years of age
- •Females pregnant, or lactating mothers
- •Participant with implantable electronic devices such as pacemakers or implantable cardioverter-defibrillator (ICD)
- •Participant has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study evaluation
研究组 & 干预措施
Evidence of abnormal cardiopulmonary exam and control group without abnormal exam
结局指标
主要结局
The secondary objection is validity and accuracy Between HALD Vest Audio Recordings and Clinical Auscultation Findings
时间窗: 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.
时间窗: 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.
时间窗: 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 )
时间窗: 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.
次要结局
未报告次要终点