Non-Invasive Lung Water Monitoring in Pulmonary Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-03-31

Brief Summary

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The investigators conducted a prospective, convenience-sampled observational pilot study, enrolling adult patients with pulmonary hypertension who were either outpatients or inpatients in the cardiology department of our hospital. The measurement of Remote Dielectric Sensing (ReDS) values was performed by ReDS™ Pro. Data were collected using the electronic medical record system of our hospital. Participants were followed up within 6 months after discharge. The primary endpoints included all-cause mortality or clinical deterioration related to pulmonary hypertension.

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Detailed Description

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The investigators conducted a prospective, convenience-sampled observational pilot study, enrolling adult patients with pulmonary hypertension who were either outpatients or inpatients in the cardiology department of our hospital. The measurement of Remote Dielectric Sensing (ReDS) values was performed by ReDS™ Pro. Data were collected using the electronic medical record system of our hospital. Participants were followed up within 6 months after discharge. The primary endpoints included all-cause mortality or clinical deterioration related to pulmonary hypertension. Data were collected using the electronic medical record system of our hospital, including demographics, clinical diagnoses, past medical history, ancillary examinations and laboratory test, surgical procedures, and medication use. Treatment and management of participants were in accordance with guideline recommendations. Participants were followed up by telephone or outpatient visits within 6 months after discharge.

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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lung fluid

The measurement of ReDS values was performed with the patient in a seated position and under normal breathing conditions. It was conducted on the morning of the second day following admission or at the end of an outpatient visit. The device's sensors or vest were properly placed on the patient's chest to ensure good contact between the sensors and the skin. Upon initiating the measurement program, the device emitted low-power electromagnetic signals that passed through the thorax and lungs. It measured the dielectric constant (impedance) of the lungs and calculated the percentage of lung fluid. The manufacturer-recommended normal range is between 20% and 35%. The entire measurement process took approximately 45 seconds.

Remote Dielectric Sensing

Intervention Type DEVICE

The lung fluid monitor Remote Dielectric Sensing (ReDS™) is the world's first non-invasive device for heart failure monitoring and management. It directly reflects lung fluid content by measuring changes in thoracic dielectric constants, with a detection range of 15% \~ 60%. The device can sensitively identify pathological states ranging from mild compensation to severe pulmonary edema. ReDS™ technology cannot directly measure pulmonary artery pressure, but changes in lung fluid content may indirectly reflect disease progression in certain types of pulmonary hypertension.

Interventions

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Remote Dielectric Sensing

The lung fluid monitor Remote Dielectric Sensing (ReDS™) is the world's first non-invasive device for heart failure monitoring and management. It directly reflects lung fluid content by measuring changes in thoracic dielectric constants, with a detection range of 15% \~ 60%. The device can sensitively identify pathological states ranging from mild compensation to severe pulmonary edema. ReDS™ technology cannot directly measure pulmonary artery pressure, but changes in lung fluid content may indirectly reflect disease progression in certain types of pulmonary hypertension.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 and ≤85 years, with no gender restriction;
* Hemodynamic confirmation of PH via right heart catheterization (RHC) (mean pulmonary arterial pressure \[mPAP\] \> 20 mmHg).

Exclusion Criteria

* Thoracic deformities or injuries precluding proper device fit (e.g., severe scoliosis, flail chest);
* Inability to use the ReDS™ Pro non-invasive lung fluid monitor due to physical characteristics (height \<155 cm or \>190 cm; body mass index \[BMI\] \<22 kg/m² or \>39 kg/m²);
* Prior implantation of a left ventricular assist device or cardiac transplantation;
* Congenital cardiac anomalies or intrathoracic masses affecting right lung anatomy;
* Hemodynamic profiles inconsistent with PH.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No