- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07241130
Using End-Tidal CO₂ to Help Diagnose and Monitor Pulmonary Embolism
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Erzurum, Turkey (Türkiye), 25200
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1: High-Risk Pulmonary Embolism (Thrombolysis)
Patients presenting with shock or persistent hypotension and receiving systemic thrombolytic therapy.
|
Participants received standard clinical management according to current pulmonary embolism guidelines.
No intervention was assigned by the investigators.
|
|
Group 2: Intermediate-High-Risk Pulmonary Embolism (Thrombolysis)
Hemodynamically stable patients with RV dysfunction and elevated biomarkers who required thrombolysis.
|
Participants received standard clinical management according to current pulmonary embolism guidelines.
No intervention was assigned by the investigators.
|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline (within first 1 hour of diagnosis)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ATA.0.01.00/427
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Embolism Acute
-
Sahlgrenska University HospitalGothia Forum - Center for Clinical TrialRecruitingPulmonary Embolism (PE) | Pulmonary Embolism With Acute Cor Pulmonale | Pulmonary Embolism With Right Ventricle Enlargement | Pulmonary Embolism Acute | Pulmonary Embolism (Diagnosis)Sweden
-
Peking Union Medical College HospitalRecruitingAcute Pulmonary EmbolismChina
-
Chinese University of Hong KongChina Medical University, TaiwanRecruitingPulmonary Embolism Subacute Massive | Pulmonary Embolism Acute | Pulmonary Embolism Acute MassiveHong Kong
-
Hospital San Carlos, MadridAsociación de Cardiología Intervencionista de la Sociedad Española de CardiologíaRecruitingPulmonary Embolism | Pulmonary Embolism and Thrombosis | Pulmonary Thromboembolisms | Pulmonary Embolism Acute | Pulmonary Embolism Acute MassiveSpain
-
Sohag UniversityNot yet recruitingAcute Pulmonary Embolism
-
Angiodynamics, Inc.Recruiting
-
Supergene, LLCNational Medical Research Center for Cardiology, Ministry of Health of Russian...RecruitingPulmonary Embolism Acute MassiveRussia
-
Massachusetts General HospitalNot yet recruitingPulmonary Embolism Acute | Pulmonary Embolism (Diagnosis)United States
-
Azienda ULSS 8 BericaRecruitingPulmonary Embolism Acute | Pulmonary Embolism (Diagnosis)Italy
Clinical Trials on thrombolytic therapy
-
Kartal Kosuyolu Yuksek Ihtisas Education and Research...UnknownObstructive ThrombusTurkey
-
All India Institute of Medical Sciences, New DelhiUnknownLeft-sided Prosthetic Heart Valve ThrombosisIndia
-
PAMI Coordinating CenterEli Lilly and Company; Guidant CorporationUnknown
-
Assiut UniversityNot yet recruiting
-
Ain Shams UniversityCompletedThrombolytic Therapy | Pulmonary Embolism Subacute MassiveEgypt
-
Fundacion para la Investigacion Biomedica del Hospital...Completed
-
HealthCore-NERINational Heart, Lung, and Blood Institute (NHLBI)CompletedMyocardial Infarction | Myocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Coronary Disease | Shock, Cardiogenic
-
Jordi Gol i Gurina FoundationCompletedIschemic Stroke | Long Term Adverse Effects | Gender Bias | Thrombolytic (t-PA) TreatmentSpain
-
Mayo ClinicEnrolling by invitationDementia | Mild Cognitive Impairment | Lewy Body Disease | Parkinsonism | REM Sleep Behavior DisorderUnited States
-
Beijing Chao Yang HospitalCompletedThromboembolism | Pulmonary EmbolismChina