Respiratory Monitoring During Right Heart

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03061669
• Other study ID #: 0370-16
• Status: Recruiting
• Start date: February 26, 2017
• Est. completion date: February 2020

Study information

• Verified date: August 2019
• Source: Rambam Health Care Campus
• Contact: Yair Feld, MD
• Phone: +972-47772181
• Email: y_feld[@]rmc.gov.il
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing right heart catheterization

Exclusion Criteria:

• Inability or unwillingness to follow or to sign the study protocol.

Related Conditions & MeSH terms

• Heart Failure
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
Israel	Rambam medical center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Technion, Israel Institute of Technology

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary artery pressure	In mmHg measured by Swan-Ganz catheter	only during the procedure of right heart catheterization
Primary	Respiratory flow	ml units	only during the procedure of right heart catheterization
Primary	Chest wall acceleration	local tidal displacement	only during the procedure of right heart catheterization
Secondary	Right ventricle pressure	In mmHg measured by Swan-Ganz catheter	only during the procedure of right heart catheterization
Secondary	Pulmonary artery wedge pressure	In mmHg measured by Swan-Ganz catheter	only during the procedure of right heart catheterization