Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-03 @ 5:09 PM
Study NCT ID:
NCT03061669
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2017-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Monitoring During Right Heart
Sponsor:
Rambam Health Care Campus
Organization:
Study Overview
Official Title:
Respiratory Monitoring During Right Heart Catheterization to Differentiate Between Various Types of Pulmonary Hypertension; The Effects of the Cardiovascular System on the Lung Mechanical Properties
Status:
UNKNOWN
Status Verified Date:
2019-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Respiratory monitoring during right heart catheterization to differentiate between various types of pulmonary hypertension; The effects of the cardiovascular system on the lung mechanical properties.
Detailed Description:
Differentiation between different kinds of pulmonary hypertension (PHTN) requires right heart catheterization. Monitoring heart failure patients is challenging in many. The study will enroll patients undergoing right heart catheterization (RHC) for the evaluation of heart failure and PHTN, based on the regular clinical practice. The regular indices as the right ventricle pressure (RVP), pulmonary artery pressure (PAP), pulmonary artery wedge pressure (PAWP), and cardiac output will be measured with the Swan Ganz Catheter and recorded.
Noninvasive measurement of the respiratory flow will be acquired by a medical approved flow-meter that is mounted on a simple plastic breathing mask.
Non-invasive system that includes three accelerometers that are attached to the chest and epigastrium of the patient will be used to measure respiratory chest wall dynamics.
Through evaluating the correlation between the invasive and non-invasive measurements the study intends to prove the ability of the non-invasive system to provide the required information.
Noninvasive measurement of the respiratory flow will be acquired by a medical approved flow-meter that is mounted on a simple plastic breathing mask.
Non-invasive system that includes three accelerometers that are attached to the chest and epigastrium of the patient will be used to measure respiratory chest wall dynamics.
Through evaluating the correlation between the invasive and non-invasive measurements the study intends to prove the ability of the non-invasive system to provide the required information.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: