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NCT01898637 · ClinicalTrials.gov registry record · NA
A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
NCT01898637: Completed NA study, sponsored by Mayo Clinic.
NCT01898637 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 64 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01898637, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Augmented pulse oximetry using incentive spirometer.
- DEVICE Incentive spirometer.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2013-06 |
| Est. Completion | 2024-11-11 |
| Phase | NA |
What the finished NCT01898637 record still lists
NCT01898637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Augmented pulse oximetry using incentive spirometer. is the first listed.
NCT01898637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01898637 about?
NCT01898637 is a clinical study titled "A Simple Clinical Tool to Help Diagnose Pulmonary Embolism: Phase 1". 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 investigat...
What is the current status of trial NCT01898637?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2013-06. Estimated completion is 2024-11-11.
What interventions are being tested in trial NCT01898637?
The interventions under investigation include: Augmented pulse oximetry using incentive spirometer. (OTHER), Incentive spirometer. (DEVICE).
Who is sponsoring clinical trial NCT01898637?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01898637's enrollment target sits among peer trials
64 1147th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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