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The goal of this project is to determine if the change in oxygen saturation during deep inspiration ("augmented pulse oximetry") can be used as a method to rule out pulmonary embolism (PE). The investigators propose to evaluate a simple, non-invasive clinical tool to help rule out PE. The investigators plan to measure the oxygen saturation of 40 consecutive patients with newly-diagnosed PE (within 60 minutes of diagnosis) and 80 matched controls who do not have a PE. Trained, blinded Respiratory Therapists or Study Coordinators will record each patient's oxygen saturation before, during, and after a 2-minute period of deep inspirations (vital capacity [the maximal amount of air that can be inhaled, measured in milliliters]) using an incentive spirometer. The investigators' central hypothesis is that persons with a PE will not respond to augmented pulse oximetry and will not significantly improve or normalize their oxygen saturation.
Patients will be identified and enrolled by the Mayo Clinic St. Marys Emergency Department staff as they are undergoing medical care in the Emergency Department.
The investigators will calculate the difference in oxygen saturation pre- and post-deep inspiration (ΔSpO2 at 1 minute, 2 minutes and 4 minutes), and then correlate these values with the CT result.
In cases of PE, The investigators expect the SpO2 to remain unchanged, or to change less than 3-5%. The investigators expect alternate hypoxemic conditions to have a significantly greater increase in SpO2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proven pulmonary embolism. | Active Comparator | Augmented pulse oximetry using incentive spirometer. Emergency Department patients with pulmonary embolism. |
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| Control patients | Other | Augmented pulse oximetry using incentive spirometer. Emergency Department patients who do not have pulmonary embolism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented pulse oximetry using incentive spirometer. | Other | Augmented pulse oximetry using incentive spirometer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in oxygen saturation using augmented pulse oximetry for patients with and without pulmonary embolism. | Trained, blinded Respiratory Therapists or Study Coordinators will record each patient's oxygen saturation before, during, and after a 2-minute period of deep inspirations (vital capacity) using an incentive spirometer. The investigators will calculate the difference in oxygen saturation pre- and post-deep inspiration (ΔSpO2 at 1 minute, 2 minutes and 4 minutes), and then correlate these values with the CT result. | Oxygen saturation (SpO2) will be recorded prior to using the spirometer, at 1 minute (during use of the spirometer), at 2 minutes (at the end of using the spirometer), and at 4 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Vital capacity (the maximal amount of air that can be inhaled, measured in milliliters) during augmented pulse oximetry. | The single maximum value obtained before, during, or after use of the incentive spirometer. | The single maximum value obtained prior to using the spirometer, at 1 minute (during use of the spirometer), at 2 minutes (at the end of using the spirometer), and at 4 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be under the care of the Emergency Department team who have the skills and resources to monitor and treat patients if they were to become unstable.
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| Name | Affiliation | Role |
|---|---|---|
| A. S. Keller, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D000860 | Hypoxia |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| Incentive spirometer. | Device | The incentive spirometer is a simple passive device that measures the amount of air a person can inhale. |
|
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |