Augmented Pulse Oximetry for Pulmonary Embolism

Recruiting in Palo Alto (17 mi)

Overseen byA. S. Keller, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with a new diagnosis of pulmonary embolism (PE) who have an oxygen saturation level below 92% and can follow study procedures. It excludes those unable to use the incentive spirometer, non-English speakers, patients from Federal Medical Center in Rochester, Minnesota, or those with certain unstable vital signs.

Inclusion Criteria

I am 18 years old or older.

My oxygen levels are below 92% without extra oxygen, and I have a new pulmonary embolism diagnosis.

Agrees and able to participate in the study

Exclusion Criteria

Your blood pressure is lower than 100 mm Hg when your heart is squeezing.

My oxygen levels are below 85% even with more than 4L of extra oxygen.

Patients from the Federal Medical Center in Rochester, Minnesota

+4 more

Participant Groups

The study tests if 'augmented pulse oximetry' using deep breaths measured by an incentive spirometer can help rule out PE. It involves comparing oxygen levels before, during, and after deep breathing in 40 patients with PE and 80 without.

2Treatment groups

Experimental Treatment

Active Control

Group I: Control patientsExperimental Treatment2 Interventions

Augmented pulse oximetry using incentive spirometer. Emergency Department patients who do not have pulmonary embolism.

Group II: Proven pulmonary embolism.Active Control2 Interventions

Augmented pulse oximetry using incentive spirometer. Emergency Department patients with pulmonary embolism.