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

Last updated: December 15, 2022
Sponsor: Poudre Valley Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Trauma

Treatment

N/A

Clinical Study ID

NCT04100512
OPEP7292019
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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

Total Participants: 50
Study Start date:
October 21, 2019
Estimated Completion Date:
October 31, 2023

Study Description

Patients identified through screening procedures to fit the inclusion criteria will be approached, within 48 hours of floor admission, to participate in the study. Once written informed consent is obtained, participants will be randomized, in a 1:1 ratio, into either the IS or OPEP study group.

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.

Connect with a study center

  • Medical Center of the Rockies

    Loveland, Colorado 80538
    United States

    Active - Recruiting

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