Pulmonary EmbolismNCT01898637
A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1
A study testing Augmented pulse oximetry using incentive spirometer. and Incentive spirometer. in people with Pulmonary Embolism, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Augmented pulse oximetry using incentive spirometer. and Incentive spirometer.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 11 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pulmonary Embolism
- Being tested
- Augmented pulse oximetry using incentive spirometer., Incentive spirometer.
- Keywords
- pulmonary embolism, pulse oximetry, change in oxygen saturation, hypoxemia, emergency department, deep inspiration, vital capacity, clinical diagnosis
- Medical subject headings
- Pulmonary Embolism, Hypoxia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented pulse oximetry using incentive spirometer.Other
Augmented pulse oximetry using incentive spirometer.
Incentive spirometer.Device
Also called AirLife Volumetric Incentive Spirometer.
The incentive spirometer is a simple passive device that measures the amount of air a person can inhale.
| Study group | Role | What they receive |
|---|---|---|
| Proven pulmonary embolism. | Active comparator | Augmented pulse oximetry using incentive spirometer. Emergency Department patients with pulmonary embolism. Receives: Other: Augmented pulse oximetry using incentive spirometer.; Device: Incentive spirometer. |
| Control patients | Other | Augmented pulse oximetry using incentive spirometer. Emergency Department patients who do not have pulmonary embolism. Receives: Other: Augmented pulse oximetry using incentive spirometer.; Device: Incentive spirometer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJun 2013
- Primary completion11 Nov 2024
- Study completion11 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Keller, Mayo Clinic
- Investigators
- A. S. Keller, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898637
- Sponsor's protocol ID
- 12-009527
- Status last verified
- Mar 2025
- First submitted
- 28 Jun 2013
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1
- ClinicalTrials.gov ID
- NCT01898637
- Acronym / sponsor ID
- 12-009527
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, pulse oximetry, change in oxygen saturation, hypoxemia, emergency department, deep inspiration, vital capacity, clinical diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 11 Nov 2024 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proven pulmonary embolism. | Active comparator | Other: Augmented pulse oximetry using incentive spirometer., Device: Incentive spirometer.Augmented pulse oximetry using incentive spirometer. Emergency Department patients with pulmonary embolism. |
| Control patients | Other | Other: Augmented pulse oximetry using incentive spirometer., Device: Incentive spirometer.Augmented pulse oximetry using incentive spirometer. Emergency Department patients who do not have pulmonary embolism. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented pulse oximetry using incentive spirometer.Augmented pulse oximetry using incentive spirometer. | Other | Control patients, Proven pulmonary embolism. |
| Incentive spirometer.Also: AirLife Volumetric Incentive Spirometer.The incentive spirometer is a simple passive device that measures the amount of air a person can inhale. | Device | Control patients, Proven pulmonary embolism. |
Primary outcome
Change in oxygen saturation using augmented pulse oximetry for patients with and without pulmonary embolism.
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.
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.
1 secondary outcome
Vital capacity (the maximal amount of air that can be inhaled, measured in milliliters) during augmented pulse oximetry.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. S. Keller, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented pulse oximetry using incentive spirometer. and Incentive spirometer. in people with Pulmonary Embolism, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in oxygen saturation using augmented pulse oximetry for patients with and without pulmonary embolism. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.