Rib FracturesNCT04909463
Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma
A study testing Chest Splint in people with Rib Fractures and Rib Fracture Multiple, run by CommonSpirit Health at 1 site in United States.
Trial summary
The purpose of this study is to use the Duracore splinting device to measure lung capacities of patients with rib fractures in control and experimental groups to determine if lung capacities improve with the splint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rib Fractures, Rib Fracture Multiple
- What is being tested?
- Chest Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patient admitted to the trauma service at Penrose Hospital
- Willing and able to comply with all requirements of the study
- Active diagnosis of rib fractures
- Male or female 18 years and older
- Able to provide written informed consent to participate in the study
- Must be physically able to don and use the splinting device independently without assistance.
Who cannot join
- <18 years old
- History of pulmonary disease, lobectomy, or lung transplant
- Current smoker of tobacco products
- Diagnosis of flail chest
- Pregnant Women
- Prisoners
- Cognitively Impaired; must be alert and oriented x 3
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to use the Duracore splinting device to measure lung capacities of patients with rib fractures in control and experimental groups to determine if lung capacities improve with the splint.
Read the detailed description
The purpose of this study is to use the Duracore patient operated torso splinting device for patients with chest trauma, including rib fractures, to improve deep breathing and help with reduced hospital length of stays (LOS). The hypothesis of this study is that the use of the Duracore splinting device will reduce hospital length of stays and improve patient lung capacities over the course of admission following chest trauma.
The study will use a randomized-experimental design and will be randomized via envelope randomization, with experimenters being blinded. A total of 104 patients, 26 in each group, will undergo initial incentive spirometry and forced vital capacity (FVC) and forced expiratory volume at 1 second (FEV1) tests. Number of subjects to be used are 150 to account for withdrawals, incomplete data sets, extraneous results, etc. Groups will consist of a control versus experimental group, stratified into bilateral and unilateral rib fractures. Three days' worth of data will be collected for each of the tests and will also be collected 24 hours prior to discharge. Length of stays will be compared for experimental and control groups, as well as time to ambulation (collected from the first physical therapy assessment). Injury severity score will also be collected to determine any correlation by severity of injury. Patient satisfaction surveys for the device will also be collected to determine if the patients feel a difference with the device.
Little research as been conducted to determine the significance of a splinting device used in patients with chest trauma, and it is still uncertain whether these devices improve overall patient outcomes. Contradicting studies with similar experimental designs show either some significance (p-value) or insignificance in pulmonary function pre- and post-treatment. This gap in current knowledge leaves room for concern in whether the patient truly benefits from a splinting device in this type of injury. Changes in FVC/FEV1 ratio in this patient population are not readily demonstrated in most of these studies, as well as differing length of stays. This study will contribute to this base of knowledge by determining the effects of the Duracore splinting device on this patient population using the objectives.
- Conditions
- Rib Fractures, Rib Fracture Multiple
- Being tested
- Chest Splint
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest SplintDevice
Also called Duracore
Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral rib fractures only, no device intervention | No intervention | Unilateral rib fractures only, no device intervention |
| Unilateral rib fractures, device intervention | Experimental | Unilateral rib fractures, will receive device intervention Receives: Device: Chest Splint |
| Bilateral rib fractures, no device intervention | No intervention | Bilateral rib fractures, no device intervention |
| Bilateral rib fractures, device intervention | Experimental | Bilateral rib fractures, will receive device intervention Receives: Device: Chest Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC Change
Change in forced vital capacities over time using the device as compared to control groups
Measured: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
FEV1 Change
Change in forced expiratory volume in one second over hospital duration using the device as compared to control groups
Measured: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
FEV1 Percent Change
Change in FEV1/FVC ratio (expressed as FEV1%) over hospital duration using the device as compared to control groups
Measured: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Secondary outcomes (5)
Length of Stay
The length of stay for the entire admission to the time of discharge
Measured: Documented at time of discharge, assessed up to 14 days.
Time to Ambulation
The initial time of ambulation documented after admission.
Measured: 0-48 hours after admission.
Injury Severity Score
Use of the Injury Severity Score to measure the degree of injury and how it affects outcomes associated with the chest splint. This is measured on a scale from 1 to 6; 1 being relatively minor and 6 being untreatable.
Measured: Documented within 2 weeks of admission date.
Day of Admission
Documenting date and time of admission
Measured: Within first 24 hours of admission
Vital Capacity Measurement Via Incentive Spirometry
Change in vital capacity values indicating changes in deep breathing over the course of hospitalization while using the Duracore device
Measured: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start4 Dec 2020
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Why it stopped: Limited resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- CommonSpirit Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trenton Bradbury, CommonSpirit Health
- Investigators
- Trenton Bradbury, BS, Principal investigator, CommonSpirit Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909463
- Sponsor's protocol ID
- 1517921
- Status last verified
- Apr 2025
- First submitted
- 4 Jan 2021
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared. All information pertaining to statistical significance or lack thereof will be outlined in the final study publication.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma
- ClinicalTrials.gov ID
- NCT04909463
- Acronym / sponsor ID
- 1517921
- Conditions
- Rib Fractures, Rib Fracture Multiple
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited resources
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CommonSpirit HealthUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use the Duracore splinting device to measure lung capacities of patients with rib fractures in control and experimental groups to determine if lung capacities improve with the splint.
Detailed description
The purpose of this study is to use the Duracore patient operated torso splinting device for patients with chest trauma, including rib fractures, to improve deep breathing and help with reduced hospital length of stays (LOS). The hypothesis of this study is that the use of the Duracore splinting device will reduce hospital length of stays and improve patient lung capacities over the course of admission following chest trauma.
The study will use a randomized-experimental design and will be randomized via envelope randomization, with experimenters being blinded. A total of 104 patients, 26 in each group, will undergo initial incentive spirometry and forced vital capacity (FVC) and forced expiratory volume at 1 second (FEV1) tests. Number of subjects to be used are 150 to account for withdrawals, incomplete data sets, extraneous results, etc. Groups will consist of a control versus experimental group, stratified into bilateral and unilateral rib fractures. Three days' worth of data will be collected for each of the tests and will also be collected 24 hours prior to discharge. Length of stays will be compared for experimental and control groups, as well as time to ambulation (collected from the first physical therapy assessment). Injury severity score will also be collected to determine any correlation by severity of injury. Patient satisfaction surveys for the device will also be collected to determine if the patients feel a difference with the device.
Little research as been conducted to determine the significance of a splinting device used in patients with chest trauma, and it is still uncertain whether these devices improve overall patient outcomes. Contradicting studies with similar experimental designs show either some significance (p-value) or insignificance in pulmonary function pre- and post-treatment. This gap in current knowledge leaves room for concern in whether the patient truly benefits from a splinting device in this type of injury. Changes in FVC/FEV1 ratio in this patient population are not readily demonstrated in most of these studies, as well as differing length of stays. This study will contribute to this base of knowledge by determining the effects of the Duracore splinting device on this patient population using the objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Unilateral rib fractures only, no device intervention | No intervention | –Unilateral rib fractures only, no device intervention |
| Unilateral rib fractures, device intervention | Experimental | Device: Chest SplintUnilateral rib fractures, will receive device intervention |
| Bilateral rib fractures, no device intervention | No intervention | –Bilateral rib fractures, no device intervention |
| Bilateral rib fractures, device intervention | Experimental | Device: Chest SplintBilateral rib fractures, will receive device intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient admitted to the trauma service at Penrose Hospital
- Willing and able to comply with all requirements of the study
- Active diagnosis of rib fractures
- Male or female 18 years and older
- Able to provide written informed consent to participate in the study
Key exclusion criteria (7 listed)
- <18 years old
- History of pulmonary disease, lobectomy, or lung transplant
- Current smoker of tobacco products
- Diagnosis of flail chest
- Pregnant Women
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 |
|---|---|---|
| Chest SplintAlso: DuracoreThose receiving intervention will be given the Duracore chest splint for use throughout the trial. | Device | Bilateral rib fractures, device intervention, Unilateral rib fractures, device intervention |
Primary outcome
FVC Change
Time frame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Change in forced vital capacities over time using the device as compared to control groups
FEV1 Change
Time frame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Change in forced expiratory volume in one second over hospital duration using the device as compared to control groups
FEV1 Percent Change
Time frame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Change in FEV1/FVC ratio (expressed as FEV1%) over hospital duration using the device as compared to control groups
5 secondary outcomes
Length of Stay
Time frame: Documented at time of discharge, assessed up to 14 days.
Time to Ambulation
Time frame: 0-48 hours after admission.
Injury Severity Score
Time frame: Documented within 2 weeks of admission date.
Day of Admission
Time frame: Within first 24 hours of admission
Vital Capacity Measurement Via Incentive Spirometry
Time frame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No IPD will be shared. All information pertaining to statistical significance or lack thereof will be outlined in the final study publication.
Related trials for Rib Fractures
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INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
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Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
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Active, not recruiting
Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
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Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
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.
Trenton Bradbury, BS principal investigator
CommonSpirit Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest Splint in people with Rib Fractures and Rib Fracture Multiple, run by CommonSpirit Health 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 May 2025. 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?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC Change (time frame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge). The study lists 3 primary outcomes in all. 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 14 May 2025.