Breath Analysis Technique to Diagnose Pulmonary Embolism

This study has been completed.
Sponsor:
Collaborator:
WFD Ventures Incorporated
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00368836
First received: August 24, 2006
Last updated: September 29, 2008
Last verified: September 2008

August 24, 2006
September 29, 2008
March 2006
April 2008   (final data collection date for primary outcome measure)
Evaluating the safety and effectiveness of the BreathScreen PE as an adjunct to the use of the D-dimer in evaluating patients clinically suspected of having pulmonary embolism [ Time Frame: Measured at 45 days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00368836 on ClinicalTrials.gov Archive Site
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Breath Analysis Technique to Diagnose Pulmonary Embolism
Expired CO2/O2 Analysis to Diagnose Pulmonary Embolism

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Pulmonary Embolism
Device: BreathScreen PE
One minute of breath collection by tidal breathing into the BreathScreen PE and blood draw for D-dimer level
Experimental: 1
Breath Screen PE device + D-dimer
Intervention: Device: BreathScreen PE

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
475
June 2008
April 2008   (final data collection date for primary outcome measure)

Phase I Inclusion Criteria:

  • Experienced or is scheduled for at least one of the following:

    1. Hip or knee replacement surgery
    2. Hip or acetabular fracture surgery
    3. Pelvic fracture
    4. Decompression for spinal stenosis surgery
    5. Scoliosis corrective surgery
    6. Craniotomy surgery for brain tumor
    7. Surgery for any of the following cancers: bladder, colon (including caecum and rectum), kidney, ovary, pancreas, or uterus

Phase I Exclusion Criteria:

  • Currently undergoing treatment for PE or has received treatment for PE in the 4 weeks prior to study entry
  • Hospitalized for fewer than 2 days
  • Anatomic abnormality that would prevent use of a mouthpiece
  • Living situation that makes follow-up difficult (e.g., homeless, incarcerated)

Phase II Inclusion Criteria:

  • Clinical suspicion of PE with signs or symptom suggestive of PE within 24 hours of presentation and at least one risk factor for PE, as defined under the criteria as outlined in this protocol
  • CTA of pulmonary arteries ordered by clinical care providers
  • 18 years or older or an emancipated 17 year old
  • Written informed consent

Phase II Exclusion Criteria:

  • Hemodynamic instability, including patients with a systolic blood pressure less than 90 mm Hg
  • Severe respiratory distress or the inability to breathe room air without the sensation of severe dyspnea
  • Pulse oximetry reading that declines more than 10% when exogenous oxygen is discontinued with accompanying worsening or new dyspnea
  • Intubated
  • Cannot breathe through the mouth owing to anatomic, physical or mental limitation
  • No fixed address, no telephone number, are from out of town or have other reason to suspect difficulty with follow-up
  • Incarceration
  • Known active tuberculosis
  • Prior PE or DVT with history of medical noncompliance with oral anticoagulation therapy based upon a history of unplanned subtherapeutic INR measurements (less than 1.5)
  • Active PE within previous 6 months and currently under treatment with anticoagulation
  • Pregnant
  • Disallowed medications: treatment with any fibrinolytic agent within 48 hours prior to enrollment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00368836
433, R42 HL086316-01
Yes
National Heart Lung & Blood Institute and Dr. Jeffery A. Kline, Carolinas Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
WFD Ventures Incorporated
Principal Investigator: Jefferey A. Kline, MD Carolinas Healthcare System
National Heart, Lung, and Blood Institute (NHLBI)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP