Non-Invasive Lung Water Monitoring in Pulmonary Hypertension

Fudan University

Status: Completed

Conditions: Pulmonary Hypertension

Treatments: Device: Remote Dielectric Sensing

Study type: Observational

Funder types: Other

Identifiers

NCT06942871

ReDS in PAH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 202 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

202 participants in 1 patient group

lung fluid

Description:

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.

Treatment:

Device: Remote Dielectric Sensing