Respiratory Monitoring During Right Heart

• Conditions: Pulmonary Hypertension; Heart Failure

• Registration Number: NCT03061669
• Lead Sponsor: Rambam Health Care Campus

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.

Study Timeline

• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-19
• Study First Posted: 2017-02-23
• Study Start: 2017-02-26
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients undergoing right heart catheterization

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pulmonary artery wedge pressure	only during the procedure of right heart catheterization	In mmHg measured by Swan-Ganz catheter
Right ventricle pressure	only during the procedure of right heart catheterization	In mmHg measured by Swan-Ganz catheter

Trial Locations

Locations (1)

Rambam medical center; 🇮🇱 Haifa, Israel