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

Not Applicable

Recruiting

• Conditions: Rib Fractures; Respiratory Complication
• Interventions: Device: Incentive spirometry; Device: Oscillating Positive Expiratory Pressure Device

• Registration Number: NCT04100512
• Lead Sponsor: Poudre Valley Health System

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Study Start: 2019-10-21
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-19
• Primary Completion: 2023-08-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incentive spirometry	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.
Oscillating Positive Expiratory Pressure Device	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.

Primary Outcome Measures

Name	Time	Method
Time (hours) to stable forced vital capacity	3 times daily, until FVC is >1.5 liters x 4 consecutive tests, or up to 4 weeks	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.

Trial Locations

Locations (1)

Medical Center of the Rockies; 🇺🇸 Loveland, Colorado, United States