Rib FracturesNCT04100512
Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures
A study testing Oscillating Positive Expiratory Pressure Device and Incentive spirometry in people with Rib Fractures and Respiratory Complication, run by Poudre Valley Health System at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Respiratory Complication
- What is being tested?
- Oscillating Positive Expiratory Pressure Device and Incentive spirometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2019to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- Moderate to severe Traumatic brain injury (Glasgow Coma Scale < 12)
- Cervical spinal cord injury
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Julie Dunn, MD, 970-624-1689, julie.dunn@uchealth.org
About this study
Official title: Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures: A Randomized Comparative Trial Against Incentive Spirometry
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).
Read the 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.
- Conditions
- Rib Fractures, Respiratory Complication
- Being tested
- Oscillating Positive Expiratory Pressure Device, Incentive spirometry
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillating Positive Expiratory Pressure DeviceDevice
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 spirometryDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Incentive spirometry | Active comparator | 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. Receives: Device: Incentive spirometry |
| Oscillating Positive Expiratory Pressure Device | Experimental | 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. Receives: Device: Oscillating Positive Expiratory Pressure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 times daily, until FVC is >1.5 liters x 4 consecutive tests, or up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start21 Oct 2019
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Monaghan Medical Corporation
- Responsible party
- Principal investigator, Julie Dunn, M.D., Poudre Valley Health System
- Investigators
- Julie Dunn, MD, Principal investigator, Trauma Research Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100512
- Sponsor's protocol ID
- OPEP7292019
- Status last verified
- Dec 2022
- First submitted
- 17 Sep 2019
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures: A Randomized Comparative Trial Against Incentive Spirometry
- ClinicalTrials.gov ID
- NCT04100512
- Acronym / sponsor ID
- OPEP7292019
- Conditions
- Rib Fractures, Respiratory Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Collaborators
- Monaghan Medical Corporation
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive spirometry | Active comparator | Device: Incentive spirometryEach 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 | Experimental | Device: Oscillating Positive Expiratory Pressure DeviceEach 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oscillating Positive Expiratory Pressure DeviceAerobika® 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. | Device | Oscillating Positive Expiratory Pressure Device |
| Incentive spirometryAn 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. | Device | Incentive spirometry |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Dunn, MD principal investigator
Trauma Research Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oscillating Positive Expiratory Pressure Device and Incentive spirometry in people with Rib Fractures and Respiratory Complication, run by Poudre Valley Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Dunn, MD (970.624.1689, julie.dunn@uchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.