Respiratory Monitoring During Right Heart

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Pulmonary Hypertension

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Yair Feld, MD; Phone Number: +972-47772181; Email: y_feld@rmc.gov.il

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Medical Center
    • Contact: Yair Feld, MD; Phone Number: +972-4-7772181; Email: y_feld@rmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing right heart catheterization (RHC) for the evaluation of heart failure and pulmonary hypertension, based on the regular clinical practice.

Description

Inclusion Criteria:

• Patients undergoing right heart catheterization

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary artery pressure	In mmHg measured by Swan-Ganz catheter	only during the procedure of right heart catheterization
Respiratory flow	ml units	only during the procedure of right heart catheterization
Chest wall acceleration	local tidal displacement	only during the procedure of right heart catheterization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricle pressure	In mmHg measured by Swan-Ganz catheter	only during the procedure of right heart catheterization
Pulmonary artery wedge pressure	In mmHg measured by Swan-Ganz catheter	only during the procedure of right heart catheterization

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Collaborators: Technion, Israel Institute of Technology
• Investigators: Principal Investigator: Yair Feld, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2017
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 19, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: heart failure; pulmonary hypertension; right heart catheterization
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Heart Failure; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 0370-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No