← Back to Search

Augmented Pulse Oximetry for Pulmonary Embolism

N/A

Waitlist Available

Led By A. S. Keller, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or greater

Room air SpO2 (oxygen saturation) less than 92% and newly-diagnosed PE (or controls with no PE) based on CT angiogram result

Must not have

Oxygen saturation less than 85% with more than 4 L supplemental oxygen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to see if a change in oxygen saturation during deep inspiration can be used to rule out pulmonary embolism.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial uses non-invasive augmented pulse oximetry via an incentive spirometer for diagnosis rather than treatment, significant side effects are not anticipated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.