Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures

NCT04100512 | Unknown FDA Device

• 1 other identifier: OPEP7292019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of oscillatory positive expiratory pressure (OPEP) therapy on patients admitted through the trauma service line for rib fractures, as compared to incentive spirometry (IS).

Conditions

Rib Fractures; Respiratory Complication

Outcome Measures

Primary Outcomes (1)

• Time (hours) to stable forced vital capacity

  Time (hours) to stable forced vital capacity (FVC) defined as \>1.5 liters x 4 tests and FVC at 7 days for both IS and OPEP participants.

  3 times daily, until FVC is >1.5 liters x 4 consecutive tests, or up to 4 weeks

Study Arms (2)

Incentive spirometry

ACTIVE COMPARATOR

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.

Device: Incentive spirometry

Oscillating Positive Expiratory Pressure Device

EXPERIMENTAL

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.

Device: Oscillating Positive Expiratory Pressure Device

Interventions

Oscillating Positive Expiratory Pressure Device 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.

Oscillating Positive Expiratory Pressure Device

Incentive spirometry DEVICE

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.

Incentive spirometry

Eligibility Criteria

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

You may qualify if:

• Greater than or equal to 18 years old
• Greater than or equal to 1 Rib Fracture
• Admitted to trauma services at Medical Center of the Rockies (MCR).

You may not qualify if:

• Less than 18 years old
• 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

Sponsors & Collaborators

• Poudre Valley Health System: lead
• Monaghan Medical Corporation: collaborator

Study Sites (1)

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

RECRUITING

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• Julie Dunn, MD

  Trauma Research Medical Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Dunn, MD

CONTACT

970.624.1689; julie.dunn@uchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trauma Research Medical Director

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 24, 2019
• Study Start: October 21, 2019
• Primary Completion: August 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

US (1)