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

Sponsor
Suremedix Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04509089
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
3
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Suremedix Device
 N/A

Study Design

Study Type:
Interventional
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 :
Dec 1, 2020
Actual Primary Completion Date :
Jan 29, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Rabin Medical Center Petah Tikva Israel 49100

Sponsors and Collaborators

  • Suremedix Ltd

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Suremedix Ltd
ClinicalTrials.gov Identifier:
NCT04509089
Other Study ID Numbers:
  • CIP-001
First Posted:
Aug 11, 2020
Last Update Posted:
Aug 4, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Aug 4, 2021