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

July 28, 2021 updated by: Suremedix Ltd
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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Petah Tikva, Israel, 49100
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Congestive heart failure patients scheduled for pulmonary artery catheterization (Swan-Ganz)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Ben Ben Avraham, MD, Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

January 29, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

August 8, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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