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

NCT ID: NCT07190079

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 343 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-24
• Study Completion Date: 2027-09-15

Brief Summary

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.

Conditions

Acute Pulmonary Embolism

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients clinically suspected with acute PE

This study will enroll adult patients (\>18 years) with clinically suspected or confirmed acute pulmonary embolism (PE) presenting with acute respiratory failure, who either undergo computed tomography pulmonary angiography (CTPA) within 24 hours or are scheduled for CTPA within the next 24 hours. Eligible participants need to have an indwelling central venous catheter (internal jugular or subclavian vein) or a peripheral forearm venous line, with no restrictions on gender.

Saline contrast Electrical Impedance Tomography method

Intervention Type: DIAGNOSTIC_TEST

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: Expiratory hold (>8 sec) achieved via ventilator; deeper sedation will be applied when feasible to prolong breath-hold.

2. Venous Access: (1)Preferred: Central venous catheter (internal jugular or subclavian vein).(2)Alternative: Peripheral forearm vein (preferably the median cubital vein).

3. Contrast Administration:(1)Central venous route: 10 mL of 10% NaCl.(2)Peripheral venous route: 15 mL of 5% NaHCO₃.

Computed Tomography Pulmonary Angiography (CTPA)

Intervention Type: DIAGNOSTIC_TEST

Patients who meet the inclusion criteria will undergo CTPA examination using conventional clinical diagnostic methods.

Interventions

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: Expiratory hold (>8 sec) achieved via ventilator; deeper sedation will be applied when feasible to prolong breath-hold.

2. Venous Access: (1)Preferred: Central venous catheter (internal jugular or subclavian vein).(2)Alternative: Peripheral forearm vein (preferably the median cubital vein).

3. Contrast Administration:(1)Central venous route: 10 mL of 10% NaCl.(2)Peripheral venous route: 15 mL of 5% NaHCO₃.

Intervention Type: DIAGNOSTIC_TEST

Computed Tomography Pulmonary Angiography (CTPA)

Patients who meet the inclusion criteria will undergo CTPA examination using conventional clinical diagnostic methods.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Patients with clinically suspected or confirmed acute pulmonary embolism (PE) presenting with acute respiratory failure;

2. Availability of CTPA results within 24 hours or scheduled to undergo CTPA within the next 24 hours;

3. Age >18 years; no gender restrictions;

4. Presence of central venous access (internal jugular or subclavian vein) or peripheral forearm venous access;

5. Willingness to participate with signed informed consent from either the patient or legal guardian.

Exclusion Criteria

1. Pregnancy or lactation;

2. Relative contraindications to EIT examination (e.g., chest wall wounds at electrode belt placement site, presence of pacemakers);

3. Severe hypernatremia (serum sodium >155 mmol/L);

4. Inability to maintain expiratory breath-hold for ≥8 seconds;

5. BMI >50 or severe thoracic deformities;

6. Current extracorporeal membrane oxygenation (ECMO) therapy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huaiwu He

Role: CONTACT

tjmuhhw@163.com

01069152301

Facility Contacts

Huaiwu He

Role: primary

tjmuhhw@163.com

01069152301

Other Identifiers

ECTPED

Identifier Type: -

Identifier Source: org_study_id