An interventional study of Chest Splint in Rib Fractures and Rib Fracture Multiple, sponsored by CommonSpirit Health. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by CommonSpirit Health · Not applicable, Interventional, and Treatment
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.
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.
126 studies on the registry are indexed under Rib Fractures; 28 are open to participants now.
This study's enrollment of 8 is below the median of 60 across 92 interventional studies indexed under Rib Fractures.
Browse Rib Fractures studies →CommonSpirit Health is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Unilateral rib fractures only, no device intervention
Unilateral rib fractures, will receive device intervention
Device: Chest Splint
Bilateral rib fractures, no device intervention
Bilateral rib fractures, will receive device intervention
Device: Chest Splint
Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
Also known as: Duracore
FVC Change
Change in forced vital capacities over time using the device as compared to control groups
Time frame: 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
Time frame: 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
Time frame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Length of Stay
The length of stay for the entire admission to the time of discharge
Time frame: Documented at time of discharge, assessed up to 14 days.
Time to Ambulation
The initial time of ambulation documented after admission.
Time frame: 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.
Time frame: Documented within 2 weeks of admission date.
Day of Admission
Documenting date and time of admission
Time frame: 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
Time frame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
| Milestone | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention |
|---|---|---|---|---|
| Started | 3 | 4 | 1 | 0 |
| Completed | 1 | 2 | 0 | 0 |
| Not completed | 2 | 2 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 | 0 |
Change in forced vital capacities over time using the device as compared to control groups
| Liters (L) | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention |
|---|---|---|---|---|
| FVC Change | 0.06 ± 0 | 0.34 ± 0.33 | — | — |
Change in forced expiratory volume in one second over hospital duration using the device as compared to control groups
| Liters (L) | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention |
|---|---|---|---|---|
| FEV1 Change | 0.03 ± 0 | 0.33 ± 0.46 | — | — |
Change in FEV1/FVC ratio (expressed as FEV1%) over hospital duration using the device as compared to control groups
| Percentage (%) | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention |
|---|---|---|---|---|
| FEV1 Percent Change | -0.63 ± 0 | 4.49 ± 12.40 | — | — |
The length of stay for the entire admission to the time of discharge
| Days | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention |
|---|---|---|---|---|
| Length of Stay | 2 ± 0 | 4.5 ± 2.12 | — | — |
The initial time of ambulation documented after admission.
| Hours | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention |
|---|---|---|---|---|
| Time to Ambulation | 19.8 ± 0 | 22.75 ± 3.46 | — | — |
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.
| score | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention |
|---|---|---|---|---|
| Injury Severity Score | 9 ± 0 | 2.5 ± 2.12 | — | — |
Documenting date and time of admission
| Participants | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention |
|---|---|---|---|---|
| Day of Admission | 1 | 2 | — | — |
Change in vital capacity values indicating changes in deep breathing over the course of hospitalization while using the Duracore device
| Liters (L) | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention |
|---|---|---|---|---|
| Vital Capacity Measurement Via Incentive Spirometry | 0.20 ± 0 | 0.95 ± 0.21 | — | — |
Collected over 7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unilateral Rib Fractures Only, no Device Intervention | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Unilateral Rib Fractures, Device Intervention | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Bilateral Rib Fractures, no Device Intervention | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Bilateral Rib Fractures, Device Intervention | — | — | — |
lack of available subjects due to the covid19 pandemic
| Age, Categorical(Participants) | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 3 | 1 | — | 5 |
| >=65 years | 2 | 1 | 0 | — | 3 |
| Sex: Female, Male(Participants) | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention | Total |
|---|---|---|---|---|---|
| Female | 2 | 2 | 0 | — | 4 |
| Male | 1 | 2 | 1 | — | 4 |
| Race and Ethnicity Not Collected(Participants) | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No IPD will be shared. All information pertaining to statistical significance or lack thereof will be outlined in the final study publication.
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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