Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368836
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2006-08-24
Brief Title:
Breath Analysis Technique to Diagnose Pulmonary Embolism
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Expired CO2O2 Analysis to Diagnose Pulmonary Embolism
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 CO2O2 pressure in an individuals 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 CO2O2 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
This study will be conducted in two phases In Phase I CO2O2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R42HL086316-01 | NIH | None | httpsreporternihgovquickSearchR42HL086316-01 |