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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

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

Study 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.Check my eligibility

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.See study design

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

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I am 18 years old or older.

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

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in oxygen saturation using augmented pulse oximetry for patients with and without pulmonary embolism.

Secondary outcome measures

Vital capacity (the maximal amount of air that can be inhaled, measured in milliliters) during augmented pulse oximetry.

Trial Design

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,765,583 Total Patients Enrolled

1 Trials studying Pulmonary Embolism

10,000 Patients Enrolled for Pulmonary Embolism

A. S. Keller, MDPrincipal InvestigatorMayo Clinic

1 Previous Clinical Trials

84 Total Patients Enrolled

Media Library

Control patients Clinical Trial Eligibility Overview. Trial Name: NCT01898637 — N/A

Pulmonary Embolism Research Study Groups: Proven pulmonary embolism., Control patients

Pulmonary Embolism Clinical Trial 2023: Control patients Highlights & Side Effects. Trial Name: NCT01898637 — N/A

Control patients 2023 Treatment Timeline for Medical Study. Trial Name: NCT01898637 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the recruitment period for this experiment started yet?

"According to clinicaltrials.gov, this particular study is not at present recruiting patients as its most recent update was on February 14th 2022. While the trial has halted participant recruitment, 79 other trials are actively enrolling volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Scott Keller 2013. "A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01898637.

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