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Recruiting NCT07190079

Saline Contrast Electrical Impedance Tomography Method for Diagnosis of Acute Pulmonary Embolism

Observational Acute Pulmonary Embolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saline contrast Electrical Impedance Tomography method, Computed Tomography Pulmonary Angiography (CTPA).
Who it may be relevant to
Registry conditions: Acute Pulmonary Embolism. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Multicenter Comparative Study of Saline Contrast Electrical Impedance Tomography Method Versus CTPA in the Diagnosis of Acute Pulmonary Embolism

Overview

The goal of this observational study is to compare the consistency of saline contrast Electrical Impedance Tomography(EIT) method and Computed Tomography Pulmonary Angiography (CTPA) in diagnosing acute pulmonary embolism. The main question it aims to answer is: Can bedside saline contrast EIT method be used for the diagnosis of acute pulmonary embolism? The participants will undergo saline contrast EIT and CTPA examinations successively within 24 hours.

Interventions

  • Diagnostic test Saline contrast Electrical Impedance Tomography method
    This study will enroll patients with clinically suspected or confirmed acute pulmonary embolism (PE) presenting with acute respiratory failure, who undergo electrical impedance tomography (EIT) with saline contrast within 24 hours before or after computed tomography pulmonary angiography (CTPA). The EIT procedure is performed as follows: 1. Breath-Hold Maneuver: (1)Spontaneous breathing patients: Supine position, instructed to hold expiration for ≥8 seconds. (2)Mechanically ventilated patients:
  • Diagnostic test Computed Tomography Pulmonary Angiography (CTPA)
    Patients who meet the inclusion criteria will undergo CTPA examination using conventional clinical diagnostic methods.

Primary outcome measures

  • The ability of proportion of dead space ventilation to diagnose PE [Time frame: Within 24 hours before or after the CTPA examination]
Secondary outcome measures (3)
  • The ability of proportion of V/Q matching to diagnose PE [Time frame: Within 24 hours before or after the CTPA examination]
  • The ability of proportion of shunt to diagnose PE [Time frame: Within 24 hours before or after the CTPA examination]
  • The ability of other indicators reflecting pulmonary ventilation and perfusion to diagnose PE [Time frame: Within 24 hours before or after the CTPA examination]

Eligibility criteria

Inclusion criteria

  • Patients with clinically suspected or confirmed acute pulmonary embolism (PE) presenting with acute respiratory failure;
  • Availability of CTPA results within 24 hours or scheduled to undergo CTPA within the next 24 hours;
  • Age >18 years; no gender restrictions;
  • Presence of central venous access (internal jugular or subclavian vein) or peripheral forearm venous access;
  • Willingness to participate with signed informed consent from either the patient or legal guardian.

Exclusion criteria

  • Pregnancy or lactation;
  • Relative contraindications to EIT examination (e.g., chest wall wounds at electrode belt placement site, presence of pacemakers);
  • Severe hypernatremia (serum sodium >155 mmol/L);
  • Inability to maintain expiratory breath-hold for ≥8 seconds;
  • BMI >50 or severe thoracic deformities;
  • Current extracorporeal membrane oxygenation (ECMO) therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union — Beijing

Identifiers

NCT: NCT07190079 · ECTPED

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗