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

Primary Purpose

Rib Fractures, Respiratory Complication

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oscillating Positive Expiratory Pressure Device
Incentive spirometry
Sponsored by
Poudre Valley Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rib Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Center of the RockiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Incentive spirometry

Oscillating Positive Expiratory Pressure Device

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2019
Last Updated
December 15, 2022
Sponsor
Poudre Valley Health System
Collaborators
Monaghan Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04100512
Brief Title
Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures
Official Title
Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures: A Randomized Comparative Trial Against Incentive Spirometry
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poudre Valley Health System
Collaborators
Monaghan Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures, Respiratory Complication

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Incentive spirometry
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Oscillating Positive Expiratory Pressure Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Oscillating Positive Expiratory Pressure Device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Incentive spirometry
Intervention Description
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 Information:
Title
Time (hours) to stable forced vital capacity
Description
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.
Time Frame
3 times daily, until FVC is >1.5 liters x 4 consecutive tests, or up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Dunn, MD
Phone
970.624.1689
Email
julie.dunn@uchealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Dunn, MD
Organizational Affiliation
Trauma Research Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Dunn, MD
Phone
970-624-1689
Email
julie.dunn@uchealth.org

12. IPD Sharing Statement

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

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