Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures
NCT ID: NCT04100512
Last Updated: 2022-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-10-21
2023-10-31
Brief Summary
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Detailed Description
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Each patient will be instructed on how to use the respiratory therapy device, either IS or OPEP, by research personnel and respiratory therapists. Participants will be instructed to record their compliance with the RT protocol in their respective patient diaries.
Respiratory Therapy will record FVC three times daily on all study participants until stable (FVC \> 1.5L x 4), then daily for up to 7 days or until discharge.
Participants will be contacted on day 30 from discharge, and administered a short questionnaire. All participants will be followed and monitored per standard of care, under the care and supervision of their treating provider teams.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Incentive spirometry
Each patient will be instructed on how to use the respiratory therapy device, either IS or OPEP, by research personnel and respiratory therapists. Participants will be instructed to record their compliance with the RT protocol in their respective patient diaries. Patient diaries will be collected upon discharge for analysis.
Incentive spirometry
An incentive spirometer is a device that measures how deeply you can inhale (breathe in). It helps you take slow, deep breaths to expand and fill your lungs with air. The incentive spirometer is made up of a breathing tube, an air chamber, and an indicator.
Oscillating Positive Expiratory Pressure Device
Each patient will be instructed on how to use the respiratory therapy device, either IS or OPEP, by research personnel and respiratory therapists. Participants will be instructed to record their compliance with the RT protocol in their respective patient diaries. Patient diaries will be collected upon discharge for analysis.
Oscillating Positive Expiratory Pressure Device
Aerobika® Oscillating Positive Expiratory Pressure (OPEP) device is a drug-free, easy to use, hand-held device with a proprietary pressure-oscillation dynamic that provides intermittent resistance and creates positive pressure and oscillations simultaneously. The Aerobika® OPEP device opens weak or collapsed airways to mobilize and assist mucociliary clearance to the upper airways where it can be coughed out.
Interventions
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Oscillating Positive Expiratory Pressure Device
Aerobika® Oscillating Positive Expiratory Pressure (OPEP) device is a drug-free, easy to use, hand-held device with a proprietary pressure-oscillation dynamic that provides intermittent resistance and creates positive pressure and oscillations simultaneously. The Aerobika® OPEP device opens weak or collapsed airways to mobilize and assist mucociliary clearance to the upper airways where it can be coughed out.
Incentive spirometry
An incentive spirometer is a device that measures how deeply you can inhale (breathe in). It helps you take slow, deep breaths to expand and fill your lungs with air. The incentive spirometer is made up of a breathing tube, an air chamber, and an indicator.
Eligibility Criteria
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Inclusion Criteria
* Greater than or equal to 1 Rib Fracture
* Admitted to trauma services at Medical Center of the Rockies (MCR).
Exclusion Criteria
* Any physical injury that creates inability to functionally use devices
* Adults unable to consent or cooperate due to
* Dementia
* Confusion
* On ventilator support
* Moderate to severe Traumatic brain injury (Glasgow Coma Scale \< 12)
* Cervical spinal cord injury
* Women who are pregnant
18 Years
ALL
No
Sponsors
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Monaghan Medical Corporation
UNKNOWN
Poudre Valley Health System
OTHER
Responsible Party
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Julie Dunn, M.D.
Trauma Research Medical Director
Principal Investigators
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Julie Dunn, MD
Role: PRINCIPAL_INVESTIGATOR
Trauma Research Medical Director
Locations
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Medical Center of the Rockies
Loveland, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Julie Dunn, MD
Role: primary
Other Identifiers
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OPEP7292019
Identifier Type: -
Identifier Source: org_study_id