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

Not Applicable

Completed

• Conditions: Congestive Heart Failure
• Interventions: Device: Suremedix Device

• Registration Number: NCT04509089
• Lead Sponsor: Suremedix Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-08
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-11
• Study Start: 2020-12-01
• Primary Completion: 2021-01-29
• Study Completion: 2021-03-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Suremedix Device	Congestive heart failure patients scheduled for pulmonary artery catheterization (Swan-Ganz)

Primary Outcome Measures

Name	Time	Method
Pressure waveform	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.

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel