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

Primary Purpose

Congestive Heart Failure

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Suremedix Device

About this trial

This is an interventional other trial for Congestive Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Rabin Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04509089

First Posted

August 8, 2020

Last Updated

July 28, 2021

Sponsor

Suremedix Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04509089

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

January 29, 2021 (Actual)

Study Completion Date

March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Suremedix Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congestive Heart Failure

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Suremedix Device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pressure waveform

Description

Time Frame

15 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ben Ben Avraham, MD

Organizational Affiliation

Rabin Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rabin Medical Center

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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