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

NCT01898637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-03-28

No results posted yet for this 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.

Conditions

Interventions

OTHER

Augmented pulse oximetry using incentive spirometer.

Augmented pulse oximetry using incentive spirometer.

DEVICE

Incentive spirometer.

The incentive spirometer is a simple passive device that measures the amount of air a person can inhale.

Sponsors & Collaborators

Principal Investigators

  • A. S. Keller, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2024-11-11
Completion
2024-11-11

Countries

  • United States

Study Locations

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01898637 on ClinicalTrials.gov