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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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:
• Диагностический тест Computed Tomography Pulmonary Angiography (CTPA)
  Patients who meet the inclusion criteria will undergo CTPA examination using conventional clinical diagnostic methods.

Первичные конечные точки

• The ability of proportion of dead space ventilation to diagnose PE [Срок оценки: Within 24 hours before or after the CTPA examination]

Вторичные конечные точки (3)

• The ability of proportion of V/Q matching to diagnose PE [Срок оценки: Within 24 hours before or after the CTPA examination]
• The ability of proportion of shunt to diagnose PE [Срок оценки: Within 24 hours before or after the CTPA examination]
• The ability of other indicators reflecting pulmonary ventilation and perfusion to diagnose PE [Срок оценки: Within 24 hours before or after the CTPA examination]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union — Пекин

Идентификаторы

NCT: NCT07190079 · ECTPED

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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