Recruiting

OPEP Therapy

Sponsor:

Poudre Valley Health System

Code:

NCT04100512

Conditions

Rib Fractures

Respiratory Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Oscillating Positive Expiratory Pressure Device

Incentive spirometry

Study Details

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

Study ID

NCT04100512

Start date

Oct 21, 2019

Status verified date

Dec, 2022

Completion date

Oct 31, 2023

Anticipated

Primary completion date

Aug 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

  • Time (hours) to stable forced vital capacity [ Time Frame: 3 times daily, until FVC is >1.5 liters x 4 consecutive tests, or up to 4 weeks ]

Central Contacts and Locations

Central contacts

Julie Dunn, MD

970.624.1689julie.dunn@uchealth.org

Locations

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Contacts

Julie Dunn, MD

970-624-1689julie.dunn@uchealth.org

More Information

Sponsor

Poudre Valley Health System

Last update posted

Dec 19, 2022

Last verified

Dec, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Poudre Valley Health System on 2022-12-19.