Electrical Impedance Tomography for Assessment of Pulmonary Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital
About this trial
Pulmonary hypertension is a serious and progressive disease that is difficult to treat and diagnose, mainly because its symptoms are nonspecific and often delay recognition. Early diagnosis is a major challenge. Although several tests may suggest the disease, the definitive diagnosis still requires right heart catheterization, an invasive procedure that directly measures pulmonary hemodynamics such as pulmonary artery pressure, cardiac output, and vascular resistance.
Electrical impedance tomography (EIT) is a non-invasive, radiation-free bedside monitoring method that can evaluate ventilation and pulmonary perfusion. The number of studies investigating perfusion with EIT has been increasing, since the possibility of having a safe, radiation-free, and repeatable method available at the bedside is of great clinical interest in different fields of medicine.
Our hypothesis is that EIT provides information that correlates with the findings of right heart catheterization in patients with suspected pulmonary arterial hypertension (PAH). EIT may serve as a useful screening tool prior to catheterization and may also help in risk stratification of patients with pulmonary hypertension
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a diagnosis or clinical suspicion of pulmonary arterial hypertension (PAH) and with a medical indication for right heart catheterization.
Patients evaluated at the Pulmonology Service of InCor-HCFMUSP.
Disqualifiers
Pregnancy.
Structural heart disease, such as atrial septal defect, ventricular septal defect, or valvular disease.
Cardiac arrhythmias.
Presence of a cardiac pacemaker or other implantable electronic device.
Trial design
Design model
Single group
Treatments tested in this trial
Electrical Impedance Tomography (EIT)
Diagnostic testNon-invasive, radiation-free bedside monitoring of ventilation and pulmonary perfusion. Patients will be monitored for a short period using EIT, with data analyzed offline to assess pulsatility and perfusion indices.
Right Heart Catheterization
Procedure/SurgeryStandard invasive hemodynamic assessment performed for clinical indication, including measurement of pulmonary artery pressure, cardiac output, pulmonary vascular resistance, and stroke volume. Used as the gold standard comparator for EIT-derived measures.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Diagnostic ArmExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Sensitivity (%) of Electrical Impedance Tomography (EIT)-Derived Pulsatility Amplitude for Detection of Pulmonary Hypertension Defined by Mean Pulmonary Artery Pressure
Sensitivity (%) of EIT-derived pulsatility amplitude (measured in arbitrary impedance units, ΔZ) to detect pulmonary hypertension defined as mean pulmonary artery pressure (mPAP ≥20 mmHg) measured in mmHg by Right Heart Catheterization (RHC). Diagnostic performance will be assessed using Receiver Operating Characteristic (ROC) curve analysis and area under the curve (AUC).
Time frame
At the time of right heart catheterization (baseline, single assessment)Secondary outcomes
1
Pearson or Spearman Correlation Coefficient (r) Between EIT-Derived Pulsatility Amplitude (ΔZ) and Mean Pulmonary Artery Pressure (mmHg)
Correlation coefficient (r) between EIT-derived pulsatility amplitude (ΔZ, arbitrary impedance units) and mean pulmonary artery pressure (mmHg), pulmonary vascular resistance (Wood units), cardiac output (L/min), and stroke volume (mL), all measured invasively by Right Heart Catheterization.
Time frame
At the time of right heart catheterization2
Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Fractional Area Change (%)
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Fractional Area Change (%, measured in millimeters by transthoracic echocardiography).
Time frame
Immediately after right heart catheterization (single assessment at baseline)3
Correlation Coefficient (r) Between EIT Pulsatility Amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (mm)
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Tricuspid Annular Plane Systolic Excursion (TAPSE, measured in millimeters by transthoracic echocardiography).
Time frame
Immediately after right heart catheterization (single assessment at baseline)4
Correlation Coefficient (r) Between EIT Pulsatility Amplitude and Tissue Doppler Systolic Velocity (cm/s)
Correlation between EIT-derived pulsatility amplitude (ΔZ) and Tissue Doppler Systolic Velocity (cm/s). (S', measured in millimeters by transthoracic echocardiography).
Time frame
immediately after right heart catheterizationSponsors and contacts
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Source ClinicalTrials.gov