Clinical Trials

Respiratory Monitoring During Right Heart

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patients undergoing right heart catheterization.

Exclusion Criteria:

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03061669
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rambam Health Care Campus
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yair Feld, MD
Principal Investigator Affiliation	Rambam Health Care Campus
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Israel
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Hypertension, Heart Failure

Additional Details

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.

Contact a Trial Team

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