Back to resultsA Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1
Primary Purpose
Pulmonary Embolism
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augmented pulse oximetry using incentive spirometer.
Incentive spirometer.
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Embolism focused on measuring pulmonary embolism, pulse oximetry, change in oxygen saturation, hypoxemia, emergency department, deep inspiration, vital capacity, clinical diagnosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Clinical concern for instability.
- Systolic blood pressure less than 100 mm Hg.
- Heart rate ≥140 beats per minute.
- Oxygen saturation less than 85% with more than 4 L supplemental oxygen.
- Unable to participate/comply with instructions for using the incentive spirometer.
- Patients from the Federal Medical Center in Rochester, Minnesota.
- Patients who do not speak English (due to the need for expediency).
Patients will be under the care of the Emergency Department team who have the skills and resources to monitor and treat patients if they were to become unstable.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Proven pulmonary embolism.
Control patients
Arm Description
Augmented pulse oximetry using incentive spirometer. Emergency Department patients with pulmonary embolism.
Augmented pulse oximetry using incentive spirometer. Emergency Department patients who do not have pulmonary embolism.
Outcomes
Primary Outcome Measures
Change in oxygen saturation using augmented pulse oximetry for patients with and without pulmonary embolism.
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01898637
Brief Title
A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1
Official Title
A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
pulmonary embolism, pulse oximetry, change in oxygen saturation, hypoxemia, emergency department, deep inspiration, vital capacity, clinical diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Non-Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Proven pulmonary embolism.
Arm Type
Active Comparator
Arm Description
Augmented pulse oximetry using incentive spirometer. Emergency Department patients with pulmonary embolism.
Arm Title
Control patients
Arm Type
Other
Arm Description
Augmented pulse oximetry using incentive spirometer. Emergency Department patients who do not have pulmonary embolism.
Intervention Type
Other
Intervention Name(s)
Augmented pulse oximetry using incentive spirometer.
Intervention Description
Augmented pulse oximetry using incentive spirometer.
Intervention Type
Device
Intervention Name(s)
Incentive spirometer.
Other Intervention Name(s)
AirLife Volumetric Incentive Spirometer.
Intervention Description
The incentive spirometer is a simple passive device that measures the amount of air a person can inhale.
Primary Outcome Measure Information:
Title
Change in oxygen saturation using augmented pulse oximetry for patients with and without pulmonary embolism.
Description
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.
Time Frame
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.
Secondary Outcome Measure Information:
Title
Vital capacity (the maximal amount of air that can be inhaled, measured in milliliters) during augmented pulse oximetry.
Description
The single maximum value obtained before, during, or after use of the incentive spirometer.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Clinical concern for instability.
Systolic blood pressure less than 100 mm Hg.
Heart rate ≥140 beats per minute.
Oxygen saturation less than 85% with more than 4 L supplemental oxygen.
Unable to participate/comply with instructions for using the incentive spirometer.
Patients from the Federal Medical Center in Rochester, Minnesota.
Patients who do not speak English (due to the need for expediency).
Patients will be under the care of the Emergency Department team who have the skills and resources to monitor and treat patients if they were to become unstable.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A. S. Keller, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1
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