CLINICAL TRIAL

Treatment for Pulmonary Embolism

EnrollingByInvitation · 18+ · All Sexes · Rochester, MN

This study is evaluating whether a simple, non-invasive clinical tool can be used to rule out pulmonary embolism.

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About the trial for Pulmonary Embolism

Eligible Conditions
Pulmonary Embolism · Embolism

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Incentive spirometer.
DEVICE
Augmented pulse oximetry using incentive spirometer.
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 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.
Screening: ~3 weeks
Treatment: Varies
Reporting: 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.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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..
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Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Pulmonary Embolism. Measurement will happen over the course of 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..

Change in oxygen saturation using augmented pulse oximetry for patients with and without pulmonary embolism.
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.
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.
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 BEFORE, DURING, OR AFTER USE OF THE INCENTIVE SPIROMETER.

Who is running the study

Principal Investigator
S. K.
Scott Keller, PI
Mayo Clinic

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

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Get access to this novel treatment for Pulmonary Embolism by sharing your contact details with the study coordinator.