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

NCT04509089 | Completed

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pressure waveform

  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.

  15 minutes

Study Arms (1)

Experimental

EXPERIMENTAL

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

Device: Suremedix Device

Interventions

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suremedix Ltd: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ben Ben Avraham, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2020
• First Posted: August 11, 2020
• Study Start: December 1, 2020
• Primary Completion: January 29, 2021
• Study Completion: March 1, 2021
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)