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

Pulmonary Embolism Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

• NCT number: NCT01898637
• Study type: Interventional
• Source: Mayo Clinic
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2013
• Completion date: December 2024