Acute Pulmonary EmbolismECTPEDNCT07190079
Saline Contrast Electrical Impedance Tomography Method for Diagnosis of Acute Pulmonary Embolism
An observational study of Acute Pulmonary Embolism, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- Saline contrast Electrical Impedance Tomography method and Computed Tomography Pulmonary Angiography (CTPA)
- How many people
- 343 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2025to 15 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically suspected or confirmed acute pulmonary embolism (PE) presenting with acute respiratory failure.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Huaiwu He, 01069152301, tjmuhhw@163.com
About this study
Official title: A Multicenter Comparative Study of Saline Contrast Electrical Impedance Tomography Method Versus CTPA in the Diagnosis of Acute Pulmonary Embolism
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
- Being tested
- Saline contrast Electrical Impedance Tomography method, Computed Tomography Pulmonary Angiography (CTPA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline contrast Electrical Impedance Tomography methodDiagnostic 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:
- 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.
- Venous Access: (1)Preferred: Central venous catheter (internal jugular or subclavian vein).(2)Alternative: Peripheral forearm vein (preferably the median cubital vein).
- 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)Diagnostic test
Patients who meet the inclusion criteria will undergo CTPA examination using conventional clinical diagnostic methods.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Saline contrast Electrical Impedance Tomography method; Diagnostic Test: Computed Tomography Pulmonary Angiography (CTPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of proportion of dead space ventilation to diagnose PE
The participant undergoes a saline contrast EIT examination, after which the distribution of pulmonary ventilation and perfusion will be obtained, respectively. A V-Q map will be subsequently generated. Using offline EIT data analysis tool, the proportion of lung regions with ventilation but without perfusion is calculated, representing the proportion of dead space ventilation (expressed as a percentage). Area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, Youden's index, accuracy, Kappa statistic, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) will be used to evaluate the ability of proportion of dead space ventilation to diagnose acute pulmonary embolism (PE).
Measured: Within 24 hours before or after the CTPA examination
Secondary outcomes (3)
The ability of proportion of V/Q matching to diagnose PE
Following a saline contrast EIT examination, the participant's pulmonary ventilation and perfusion distributions will be obtained, allowing for the generation of a V-Q map. Using offline EIT data analysis tool, the proportion of lung regions demonstrating both ventilation and perfusion will be calculated, representing the proportion of V/Q matching (%). Area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, Youden's index, accuracy, Kappa statistic, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) will be used to evaluate the ability of proportion of V/Q matching to diagnose acute pulmonary embolism (PE).
Measured: Within 24 hours before or after the CTPA examination
The ability of proportion of shunt to diagnose PE
Following a saline contrast EIT examination, the participant's pulmonary ventilation and perfusion distributions will be obtained, enabling the generation of a V-Q map. Using offline EIT data analysis tool, the proportion of lung regions exhibiting perfusion without ventilation will be calculated, representing the proportion of shunt (%). Area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, Youden's index, accuracy, Kappa statistic, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) will be used to evaluate the ability of proportion of shunt to diagnose acute pulmonary embolism (PE).
Measured: Within 24 hours before or after the CTPA examination
The ability of other indicators reflecting pulmonary ventilation and perfusion to diagnose PE
Following a saline contrast EIT examination, the participant's pulmonary ventilation and perfusion distributions will be obtained, and a V-Q map will be subsequently generated. Using offline EIT data analysis tool, additional indices reflecting pulmonary ventilation and perfusion will be further calculated. Area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, Youden's index, accuracy, Kappa statistic, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) will be used to evaluate the ability of other indicators reflecting pulmonary ventilation and perfusion to diagnose acute pulmonary embolism (PE).
Measured: Within 24 hours before or after the CTPA examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start24 Sep 2025
- Primary completion1 May 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 343 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190079
- Sponsor's protocol ID
- ECTPED
- Acronym
- ECTPED
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gong C, Yuan S, Xu M, Di C, Xu H, Sun X, Gao Y, Han J, Long Y, Zhao Z, He H. A multicenter comparative study of saline contrast electrical impedance tomography method versus CTPA for the diagnosis of acute pulmonary embolism: a trial protocol. BMC Med Imaging. 2026 Aug 3;26(1):570. doi: 10.1186/s12880-026-02621-8.
PubMed 42972526
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Comparative Study of Saline Contrast Electrical Impedance Tomography Method Versus CTPA in the Diagnosis of Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT07190079
- Acronym / sponsor ID
- ECTPED / ECTPED
- Conditions
- Acute Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 343 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients clinically suspected with acute PE | – | Diagnostic Test: Saline contrast Electrical Impedance Tomography method, Diagnostic Test: Computed Tomography Pulmonary Angiography (CTPA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically suspected or confirmed acute pulmonary embolism (PE) presenting with acute respiratory failure.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline contrast Electrical Impedance Tomography methodThis 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. | Diagnostic test | Patients clinically suspected with acute PE |
| Computed Tomography Pulmonary Angiography (CTPA)Patients who meet the inclusion criteria will undergo CTPA examination using conventional clinical diagnostic methods. | Diagnostic test | Patients clinically suspected with acute PE |
Primary outcome
The ability of proportion of dead space ventilation to diagnose PE
Time frame: Within 24 hours before or after the CTPA examination
The participant undergoes a saline contrast EIT examination, after which the distribution of pulmonary ventilation and perfusion will be obtained, respectively. A V-Q map will be subsequently generated. Using offline EIT data analysis tool, the proportion of lung regions with ventilation but without perfusion is calculated, representing the proportion of dead space ventilation (expressed as a percentage). Area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, Youden's index, accuracy, Kappa statistic, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) will be used to evaluate the ability of proportion of dead space ventilation to diagnose acute pulmonary embolism (PE).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 42972526Gong C, Yuan S, Xu M, Di C, Xu H, Sun X, Gao Y, Han J, Long Y, Zhao Z, He H. A multicenter comparative study of saline contrast electrical impedance tomography method versus CTPA for the diagnosis of acute pulmonary embolism: a trial protocol. BMC Med Imaging. 2026 Aug 3;26(1):570. doi: 10.1186/s12880-026-02621-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pulmonary Embolism, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaiwu He (01069152301, tjmuhhw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability of proportion of dead space ventilation to diagnose PE (time frame: Within 24 hours before or after the CTPA examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07190079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.