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

NCT ID: NCT04509089

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-03-01

Brief Summary

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Suremedix Device

Intervention Type: 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.

Interventions

Suremedix 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suremedix Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ben Ben Avraham, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

CIP-001

Identifier Type: -

Identifier Source: org_study_id