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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509089
• Other study ID #: CIP-001
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2021
• Source: Suremedix Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 1, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Suremedix Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes