Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results

Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor outcome, however, it is challenging for monitoring. The current study is designed to explore whether data generated using Suremedix Device including a pump and non-invasive sensors including, chest motion sensor, photoplethysmography (PPG), and Electrocardiography (ECG), can be used to identify detectable oscillations that are correlated with the mean, the diastolic and the systolic pressure values of the pulmonary artery, as measured using the gold-standard Swan-Ganz method.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical Center

Petah Tikva, 49100, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Heart Failure patient scheduled for right heart catheterization (Swan-Ganz)
Age range: 18 - 80 years
Pulmonary artery systolic pressure values ≤50 mmHg according to Swan - Ganz measurement
Able and willing to sign informed consent

Exclusion criteria

History or current diagnosis of asthma or any other significant pulmonary disease
Jugular access site
Atrial fibrillation
Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
Requirement for any ventilator support (including CPAP or BPAP)
Use of long-term oxygen therapy
Known upper airway obstruction
Known susceptibility to pneumothorax or pneumothorax in the medical history
Chest surgery or pacemaker implantation in the prior 6 months
Significant primary valvular disease
Major cardiovascular event within the prior 3 months
Current heavy smoker (more than one pack per day)
Any diagnosed respiratory tract infection (including upper respiratory tract), airway or lung disease or COPD exacerbation in the prior 3 months
Female patient pregnant or breast-feeding or planning to be pregnant in the next year
Diagnosis of Obstructive Sleep Apnea
Unexplained muscle weakness. Unable to comfortably lie down for 30 minutes
Current hospitalization due to CHF deterioration
Patients with a Body Mass Index (BMI) ≥ 40kg/m2
Any condition that the PI believes could interfere with the intent of the study or would make participation not in the best interest of the patient

Treatment and study plan

Suremedix Device

Device

Performing measurements using the Suremedix Device by applying gradually ascending air pressure to the subject lungs through a mouse piece while measuring respiratory chest motion, PPG and ECG.

Primary outcomes

Pressure waveform

Time frame: 15 minutes

Correlation between specific changes observed in the pressure waveform recorded by the SureMedix Device and the mean, diastolic and systolic pressure values of the pulmonary artery as measured using the gold-standard Swan-Ganz method.

Sponsors and collaborators

Lead sponsor

Suremedix Ltd

Industry

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Aug 11, 2020
Registry last updated: Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed