A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

Inclusion Criteria: - 18 years of age or greater. - Agrees and able to participate in the study. - Room air SpO2 (oxygen saturation) less than 92% and newly-diagnosed PE (or controls with no PE) based on CT angiogram result. Exclusion Criteria: - Clinical concern for instability. - Systolic blood pressure less than 100 mm Hg. - Heart rate ≥140 beats per minute. - Oxygen saturation less than 85% with more than 4 L supplemental oxygen. - Unable to participate/comply with instructions for using the incentive spirometer. - Patients from the Federal Medical Center in Rochester, Minnesota. - Patients who do not speak English (due to the need for expediency). 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.

Last updated:

7/31/2014

NCT ID:

NCT01898637

IRB Number:

12-009527