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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chest Splint | Device | Those receiving intervention will be given the Duracore chest splint for use throughout the trial. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FVC Change | Change in forced vital capacities over time using the device as compared to control groups | 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 | 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 | 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | The length of stay for the entire admission to the time of discharge | Documented at time of discharge, assessed up to 14 days. |
| Time to Ambulation | The initial time of ambulation documented after admission. |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Trenton Bradbury, BS | CommonSpirit Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penrose Hospital | Colorado Springs | Colorado | 80906 | United States |
No IPD will be shared. All information pertaining to statistical significance or lack thereof will be outlined in the final study publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Unilateral Rib Fractures Only, no Device Intervention | Unilateral rib fractures only, no device intervention |
| FG001 | Unilateral Rib Fractures, Device Intervention | Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial. |
| FG002 | Bilateral Rib Fractures, no Device Intervention | Bilateral rib fractures, no device intervention |
| FG003 | Bilateral Rib Fractures, Device Intervention | Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
lack of available subjects due to the covid19 pandemic
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| ID | Title | Description |
|---|---|---|
| BG000 | Unilateral Rib Fractures Only, no Device Intervention | Unilateral rib fractures only, no device intervention |
| BG001 | Unilateral Rib Fractures, Device Intervention | Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | FVC Change | Change in forced vital capacities over time using the device as compared to control groups | Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data. | Posted | Mean | Standard Deviation | Liters (L) | 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge |
|
7 months
The number of participants at risk for serious adverse events, all-cause mortality, and Other (Not Including Serious) Adverse Events is zero for Bilateral Rib Fractures, Device Intervention because there were no subjects in that arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unilateral Rib Fractures Only, no Device Intervention | Unilateral rib fractures only, no device intervention |
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Early termination due to subject unavailability due to the COVID-19 pandemic. Uninterpretable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trenton Bradbury | CommonSpiritHealth | 7193730213 | trenton_b1@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2020 | Jul 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012253 | Rib Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
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|
| 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. | Documented within 2 weeks of admission date. |
| Day of Admission | Documenting date and time of admission | 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 | 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge |
| Lost to Follow-up |
|
| BG002 | Bilateral Rib Fractures, no Device Intervention | Bilateral rib fractures, no device intervention |
| BG003 | Bilateral Rib Fractures, Device Intervention | Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Unilateral Rib Fractures, Device Intervention | Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial. |
| OG002 | Bilateral Rib Fractures, no Device Intervention | Bilateral rib fractures, no device intervention |
| OG003 | Bilateral Rib Fractures, Device Intervention | Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial. |
|
|
| Primary | FEV1 Change | Change in forced expiratory volume in one second over hospital duration using the device as compared to control groups | Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data. | Posted | Mean | Standard Deviation | Liters (L) | 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge |
|
|
|
| Primary | FEV1 Percent Change | Change in FEV1/FVC ratio (expressed as FEV1%) over hospital duration using the device as compared to control groups | Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data. | Posted | Mean | Standard Deviation | Percentage (%) | 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge |
|
|
|
| Secondary | Length of Stay | The length of stay for the entire admission to the time of discharge | Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data. | Posted | Mean | Standard Deviation | Days | Documented at time of discharge, assessed up to 14 days. |
|
|
|
| Secondary | Time to Ambulation | The initial time of ambulation documented after admission. | Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data. | Posted | Mean | Standard Deviation | Hours | 0-48 hours after admission. |
|
|
|
| Secondary | 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. | Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data. | Posted | Mean | Standard Deviation | score | Documented within 2 weeks of admission date. |
|
|
|
| Secondary | Day of Admission | Documenting date and time of admission | Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed admission date and time documentation for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Date and time of admission were recorded for clinical documentation purposes. No statistical analysis was performed for this outcome. | Posted | Count of Participants | Participants | Within first 24 hours of admission |
|
|
|
| Secondary | 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 | Eight participants were enrolled before early termination of the study due to the COVID-19 pandemic. Three participants contributed data for this outcome measure. Two participants were assigned to the Unilateral Rib Fractures with Device Intervention group and one participant to the Unilateral Rib Fractures without Device group. Five participants withdrew early or were discharged without providing complete outcome data. Results are summarized only for participants who contributed data. | Posted | Mean | Standard Deviation | Liters (L) | 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Unilateral Rib Fractures, Device Intervention | Unilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Bilateral Rib Fractures, no Device Intervention | Bilateral rib fractures, no device intervention | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | Bilateral Rib Fractures, Device Intervention | Bilateral rib fractures, will receive device intervention Chest Splint: Those receiving intervention will be given the Duracore chest splint for use throughout the trial. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
|