Pulmonary Embolism AcuteNCT07241130
Using End-Tidal CO₂ to Help Diagnose and Monitor Pulmonary Embolism
An observational study of Pulmonary Embolism Acute, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Pulmonary embolism (PE) can reduce blood flow in the lungs and impair gas exchange, leading to lower end-tidal carbon dioxide (EtCO₂) levels. This prospective observational study aims to evaluate whether EtCO₂ can help identify high-risk and intermediate-high-risk patients and monitor early treatment response… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Embolism Acute
- What is being tested?
- thrombolytic therapy
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2025to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Adult, Older adult
Study population: This study included adult patients diagnosed with acute pulmonary embolism who were classified as high-risk or intermediate-high-risk based on hemodynamic status, right ventricular dysfunction, and cardiac biomarker elevation. Participants were consecutively enrolled at a tertiary university medical center. The study also included a healthy control group composed of adults without cardiopulmonary disease or significant medical comorbidities. A total of 120 individuals were studied across four cohorts representing different clinical risk categories and routine treatment pathways.
Who may be able to join
- Adults aged 18 years or older Diagnosis of acute pulmonary embolism confirmed by CT pulmonary angiography (for PE groups) Classified as high-risk or intermediate-high-risk pulmonary embolism according to ESC/ERS 2019 guidelines Ability to provide informed consent For healthy control group: no history of cardiopulmonary disease, coagulation disorders, or acute medical illness
Who cannot join
- Known chronic respiratory diseases significantly affecting EtCO₂ measurement (e.g., advanced COPD, severe asthma, chronic respiratory failure) Active infection, sepsis, or acute complications of malignancy Prior thrombolytic therapy for pulmonary embolism Anatomical or technical limitations preventing reliable nasal capnography Pregnancy Individuals younger than 18 years Inability or refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of End-Tidal CO₂ Levels in the Diagnosis and Management of Patients With Pulmonary Embolism
Pulmonary embolism (PE) can reduce blood flow in the lungs and impair gas exchange, leading to lower end-tidal carbon dioxide (EtCO₂) levels. This prospective observational study aims to evaluate whether EtCO₂ can help identify high-risk and intermediate-high-risk patients and monitor early treatment response, especially during thrombolytic therapy. A total of 120 participants were included: high-risk PE, intermediate-high-risk PE patients who received thrombolysis, intermediate-high-risk PE patients treated only with anticoagulation, and healthy controls.
The study measured EtCO₂ along with oxygen saturation, heart rate, respiratory rate, perfusion index, and radiological obstruction scores. By comparing these parameters at diagnosis and during the first 24 hours, the study seeks to determine whether EtCO₂ can serve as a simple, noninvasive marker of disease severity and early hemodynamic improvement in patients with acute PE.
- Conditions
- Pulmonary Embolism Acute
- Being tested
- thrombolytic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombolytic therapyOther
Participants received standard clinical management according to current pulmonary embolism guidelines. No intervention was assigned by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: High-Risk Pulmonary Embolism (Thrombolysis) | Patients presenting with shock or persistent hypotension and receiving systemic thrombolytic therapy. Receives: Other: thrombolytic therapy | |
| Group 2: Intermediate-High-Risk Pulmonary Embolism (Thrombolysis) | Hemodynamically stable patients with RV dysfunction and elevated biomarkers who required thrombolysis. Receives: Other: thrombolytic therapy | |
| Group 3: Intermediate-High-Risk Pulmonary Embolism (Non-Thrombolysis) | Patients meeting intermediate-high-risk criteria but treated with anticoagulation only. | |
| Group 4: Healthy Controls | Individuals without cardiopulmonary disease and with normal clinical and laboratory findings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-Tidal Carbon Dioxide (EtCO₂) Level at Diagnosis
EtCO₂ level measured in mmHg using nasal capnography at the time of diagnosis to assess its ability to identify high-risk and intermediate-high-risk pulmonary embolism and to predict the need for thrombolytic therapy.
Measured: At baseline (within first 1 hour of diagnosis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Feb 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism AcuteStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bugra Kerget, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241130
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/427
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of End-Tidal CO₂ Levels in the Diagnosis and Management of Patients With Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT07241130
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/427
- Conditions
- Pulmonary Embolism Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 21 Nov 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.
Pulmonary embolism (PE) can reduce blood flow in the lungs and impair gas exchange, leading to lower end-tidal carbon dioxide (EtCO₂) levels. This prospective observational study aims to evaluate whether EtCO₂ can help identify high-risk and intermediate-high-risk patients and monitor early treatment response, especially during thrombolytic therapy. A total of 120 participants were included: high-risk PE, intermediate-high-risk PE patients who received thrombolysis, intermediate-high-risk PE patients treated only with anticoagulation, and healthy controls.
The study measured EtCO₂ along with oxygen saturation, heart rate, respiratory rate, perfusion index, and radiological obstruction scores. By comparing these parameters at diagnosis and during the first 24 hours, the study seeks to determine whether EtCO₂ can serve as a simple, noninvasive marker of disease severity and early hemodynamic improvement in patients with acute PE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: High-Risk Pulmonary Embolism (Thrombolysis) | – | Other: thrombolytic therapyPatients presenting with shock or persistent hypotension and receiving systemic thrombolytic therapy. |
| Group 2: Intermediate-High-Risk Pulmonary Embolism (Thrombolysis) | – | Other: thrombolytic therapyHemodynamically stable patients with RV dysfunction and elevated biomarkers who required thrombolysis. |
| Group 3: Intermediate-High-Risk Pulmonary Embolism (Non-Thrombolysis) | – | –Patients meeting intermediate-high-risk criteria but treated with anticoagulation only. |
| Group 4: Healthy Controls | – | –Individuals without cardiopulmonary disease and with normal clinical and laboratory findings. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study included adult patients diagnosed with acute pulmonary embolism who were classified as high-risk or intermediate-high-risk based on hemodynamic status, right ventricular dysfunction, and cardiac biomarker elevation. Participants were consecutively enrolled at a tertiary university medical center. The study also included a healthy control group composed of adults without cardiopulmonary disease or significant medical comorbidities. A total of 120 individuals were studied across four cohorts representing different clinical risk categories and routine treatment pathways.
Key inclusion criteria (1 listed)
- Adults aged 18 years or older Diagnosis of acute pulmonary embolism confirmed by CT pulmonary angiography (for PE groups) Classified as high-risk or intermediate-high-risk pulmonary embolism according to ESC/ERS 2019 guidelines Ability to provide informed consent For healthy control group: no history of cardiopulmonary disease, coagulation disorders, or acute medical illness
Key exclusion criteria (1 listed)
- Known chronic respiratory diseases significantly affecting EtCO₂ measurement (e.g., advanced COPD, severe asthma, chronic respiratory failure) Active infection, sepsis, or acute complications of malignancy Prior thrombolytic therapy for pulmonary embolism Anatomical or technical limitations preventing reliable nasal capnography Pregnancy Individuals younger than 18 years Inability or refusal to provide informed consent
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 |
|---|---|---|
| thrombolytic therapyParticipants received standard clinical management according to current pulmonary embolism guidelines. No intervention was assigned by the investigators. | Other | Group 1: High-Risk Pulmonary Embolism (Thrombolysis), Group 2: Intermediate-High-Risk Pulmonary Embolism (Thrombolysis) |
Primary outcome
End-Tidal Carbon Dioxide (EtCO₂) Level at Diagnosis
Time frame: At baseline (within first 1 hour of diagnosis)
EtCO₂ level measured in mmHg using nasal capnography at the time of diagnosis to assess its ability to identify high-risk and intermediate-high-risk pulmonary embolism and to predict the need for thrombolytic therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulmonary Embolism Acute, run by Ataturk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Dec 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End-Tidal Carbon Dioxide (EtCO₂) Level at Diagnosis (time frame: At baseline (within first 1 hour of diagnosis)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.