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

Suremedix

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Device: Suremedix Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04509089

CIP-001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Experimental

Experimental group

Description:

Congestive heart failure patients scheduled for pulmonary artery catheterization (Swan-Ganz)

Treatment:

Device: Suremedix Device