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

Rib Fractures Clinical Trial

Official title:

Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures: A Randomized Comparative Trial Against Incentive Spirometry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04100512
• Other study ID #: OPEP7292019
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2022
• Source: Poudre Valley Health System
• Contact: Julie Dunn, MD
• Phone: 970.624.1689
• Email: julie.dunn[@]uchealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Respiratory Complication
• Rib Fractures

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Medical Center of the Rockies	Loveland	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Poudre Valley Health System	Monaghan Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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