Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604468
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
A Portable Thoracic Impedance Device for Detecting Pulmonary Congestion in Heart Failure Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Portable Thoracic Impedance Device for Detecting Pulmonary Congestion in Heart Failure Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISPLAID1
Brief Summary:
This study investigates a portable thoracic bioimpedance tomography TBIT device designed to detect early lung congestion in heart failure patients The main goal is to evaluate how well the devices measurements match those obtained from lung ultrasound and other imaging techniques By detecting lung fluid build-up before symptoms worsen this device could help manage heart failure more effectively outside of hospital settings potentially improving patient care and reducing hospital admissions Participants in the study are monitored using this device along with standard imaging methods and data on heart failure symptoms are collected to understand the device39s accuracy and usability
Detailed Description:
The primary objective is to determine the correlation between TBIT measurements and B-line scores obtained via portable lung ultrasound with secondary objectives including correlations with thoracic water content from high-resolution CT scans heart failure symptoms and NT-proBNP levels adjusted for renal function Conducted as a prospective cross-sectional diagnostic study the research involves heart failure patients recruited during hospital admissions or outpatient visits at heart failure and nephrology clinics Data collected include TBIT ultrasound and CT imaging results clinical data on heart failure severity and symptom questionnaires The study will assess correlations using statistical models such as Spearmans correlation coefficient and mixed-effects models aiming to validate TBIT as a non-invasive cost-effective tool for early detection of pulmonary congestion potentially improving outpatient management and reducing heart failure-related hospitalizations Ethical considerations include informed consent confidentiality measures and ensuring participant safety with the study procedures being observational and not altering patient treatment based on TBIT results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None