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

NCT01898637 | Completed

• 1 other identifier: 12-009527
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Keywords

pulmonary embolism; pulse oximetry; change in oxygen saturation; hypoxemia; emergency department; deep inspiration; vital capacity; clinical diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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 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.

Study Arms (2)

Proven pulmonary embolism.

ACTIVE COMPARATOR

Augmented pulse oximetry using incentive spirometer. Emergency Department patients with pulmonary embolism.

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.

Other: Augmented pulse oximetry using incentive spirometer.; Device: Incentive spirometer.

Interventions

Augmented pulse oximetry using incentive spirometer. OTHER

Augmented pulse oximetry using incentive spirometer.

Control patients; Proven pulmonary embolism.

Incentive spirometer. DEVICE

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

Also known as: AirLife Volumetric Incentive Spirometer.

Control patients; Proven pulmonary embolism.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pulmonary Embolism; Hypoxia; Emergencies

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• A. S. Keller, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 12, 2013
• Study Start: June 1, 2013
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)