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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) WFD Ventures Incorporated |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00368836 |
A pulmonary embolism (PE) is a blockage in one of the arteries of the lungs, and is usually caused by a traveling blood clot. The D-dimer blood test is currently used to diagnose PEs, but it is not always accurate for individuals who have recently undergone surgery or who have inflammatory-provoking diseases. The purpose of this study is to evaluate the effectiveness of the Carboximeter, a new PE diagnostic device that measures carbon dioxide (CO2) and oxygen (O2) output, in individuals at risk for developing PEs.
Condition | Intervention | Phase |
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Pulmonary Embolism |
Device: BreathScreen PE |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Expired CO2/O2 Analysis to Diagnose Pulmonary Embolism |
Estimated Enrollment: | 475 |
Study Start Date: | March 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Breath Screen PE device + D-dimer
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Device: BreathScreen PE
One minute of breath collection by tidal breathing into the BreathScreen PE and blood draw for D-dimer level
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PE is the second leading cause of sudden, unexpected death in the United States. In 90% of the cases, it is caused by deep vein thrombosis: a blood clot forms in a vein, travels through the bloodstream, and lodges in the lungs. PE symptoms vary, and can include cough, shortness of breath, chest pain, rapid breathing, or increased heart rate. Some medical procedures and diseases activate inflammation and blood coagulation, thereby making individuals more vulnerable to PE. Surgery, kidney dialysis, cancer, connective tissue diseases, infectious diseases, and being over 70 years old put individuals at increased risk for developing PEs. A common screening test for PE is the D-dimer blood test, which measures the level of a specific protein that is released following a PE. This test, however, has proven to be an unreliable diagnostic tool for individuals who are at high risk for PE. A more reliable diagnostic tool is needed. The Carboximeter is a new device that measures the ratio of CO2/O2 pressure in an individual's expired breath. By monitoring these components, researchers may be able to accurately diagnose PEs in high risk individuals. The purpose of this study is to evaluate the effectiveness of the Carboximeter at diagnosing PE in individuals at risk for developing PEs.
This study will be conducted in two phases. In Phase I, CO2/O2 ratio and D-dimer levels will be measured prior to and following orthopedic or cancer-related surgery in 100 individuals at risk for developing PEs. In Phase II, the same measurements will be carried out on 350 high risk individuals who are experiencing PE symptoms. These individuals will also undergo computed tomography (CT) angiography and venography, in which blood flow will be visualized using x-rays. A follow-up evaluation will occur 30 days later. If any participant from Phase I or II experiences a PE or a medical condition that affects their lungs, such as asthma or chronic obstructive pulmonary disease (COPD), researchers may schedule a follow-up evaluation to obtain repeat measurements.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Phase I Inclusion Criteria:
Experienced or is scheduled for at least one of the following:
Phase I Exclusion Criteria:
Phase II Inclusion Criteria:
Phase II Exclusion Criteria:
United States, North Carolina | |
Carolinas Medical Center | |
Charlotte, North Carolina, United States, 28203 |
Principal Investigator: | Jefferey A. Kline, MD | Carolinas Healthcare System |
Responsible Party: | Carolinas Medical Center ( National Heart Lung & Blood Institute and Dr. Jeffery A. Kline ) |
Study ID Numbers: | 433, R42 HL086316-01 |
Study First Received: | August 24, 2006 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00368836 |
Health Authority: | United States: Federal Government |
Capnography Thromboembolism Arthroplasty D-dimer |
Embolism and Thrombosis Pulmonary Embolism Respiratory Tract Diseases Embolism Lung Diseases |
Vascular Diseases Fibrin fragment D Thrombosis Thromboembolism |
Cardiovascular Diseases |