Clinical trial NCT03061669: Respiratory Monitoring During Right Heart
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Hypertension
Heart Failure
Keywords: heart failure
pulmonary hypertension
right heart catheterization
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2017-02-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing right heart catheterization

Exclusion Criteria:

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

Primary outcomes:
measure: Pulmonary artery pressure
timeFrame: only during the procedure of right heart catheterization
measure: Respiratory flow
timeFrame: only during the procedure of right heart catheterization
measure: Chest wall acceleration
timeFrame: only during the procedure of right heart catheterization
Secondary outcomes:
measure: Right ventricle pressure
timeFrame: only during the procedure of right heart catheterization
measure: Pulmonary artery wedge pressure
timeFrame: only during the procedure of right heart catheterization
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam medical center
Study officials:
affiliation: Rambam Health Care Campus
name: Yair Feld, MD
role: PRINCIPAL_INVESTIGATOR
References: