Phase 3
N=350
Breath Analysis Technique to Diagnose Pulmonary Embolism
Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT00368836 ↗Enrolled (actual)
350
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Phase I: Percentage Change in the Postoperative End Tidal CO2/O2 Ratio and D-dimer Concentration Relative to the Preoperative Measurement — 0; 136 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BreathScreen PE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I: Percentage Change in the Postoperative End Tidal CO2/O2 Ratio and D-dimer Concentration Relative to the Preoperative Measurement |
0; 136 | — |
| PRIMARY Phase II: Probability of Pulmonary Embolism Diagnosis by D-dimer Alone vs. D-Dimer Plus CO2/O2 for Pulmonary Embolism Diagnosed by CT Scan. |
0.32; 0.17 | — |
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.
Eligibility Criteria
Phase I Inclusion Criteria:
- Experienced or is scheduled for at least one of the following:
- Hip or knee replacement surgery
- Hip or acetabular fracture surgery
- Pelvic fracture
- Decompression for spinal stenosis surgery
- Scoliosis corrective surgery
- Craniotomy surgery for brain tumor
- 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
Data sourced from ClinicalTrials.gov (NCT00368836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.