- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04509089
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
Conditions
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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