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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04509089
Recruitment Status : Completed
First Posted : August 11, 2020
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
Suremedix Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: Suremedix Device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results
Actual Study Start Date : December 1, 2020
Actual Primary Completion Date : January 29, 2021
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
Congestive heart failure patients scheduled for pulmonary artery catheterization (Swan-Ganz)
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04509089


Locations
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Israel
Rabin Medical Center
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Suremedix Ltd
Investigators
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Principal Investigator: Ben Ben Avraham, MD Rabin Medical Center
More Information
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Responsible Party: Suremedix Ltd
ClinicalTrials.gov Identifier: NCT04509089    
Other Study ID Numbers: CIP-001
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases