Rib Fracture Multiple, Rib Fractures
Conditions
Brief 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.
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.
Interventions
DEVICEChest Splint
Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
Sponsors
CommonSpirit Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * 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. Exclusion: * \<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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FVC Change | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Day of Admission | Within first 24 hours of admission | Documenting date and time of admission |
| Length of Stay | Documented at time of discharge, assessed up to 14 days. | The length of stay for the entire admission to the time of discharge |
| Vital Capacity Measurement Via Incentive Spirometry | 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge | Change in vital capacity values indicating changes in deep breathing over the course of hospitalization while using the Duracore device |
| Time to Ambulation | 0-48 hours after admission. | The initial time of ambulation documented after admission. |
| Injury Severity Score | Documented within 2 weeks of admission date. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unilateral Rib Fractures Only, no Device Intervention Unilateral rib fractures only, no device intervention | 3 |
| 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. | 4 |
| Bilateral Rib Fractures, no Device Intervention Bilateral rib fractures, no device intervention | 1 |
| 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 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Unilateral Rib Fractures Only, no Device Intervention | Unilateral Rib Fractures, Device Intervention | Bilateral Rib Fractures, no Device Intervention | Bilateral Rib Fractures, Device Intervention | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 0 Participants | — | 3 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 1 Participants | — | 5 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants | — | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants | — | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 4 | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 | 0 / 1 | 0 / 0 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral Rib Fractures Only, no Device Intervention | FEV1 Change | 0.03 Liters (L) | Standard Deviation 0 |
| Unilateral Rib Fractures, Device Intervention | FEV1 Change | 0.33 Liters (L) | Standard Deviation 0.46 |
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral Rib Fractures Only, no Device Intervention | FEV1 Percent Change | -0.63 Percentage (%) | Standard Deviation 0 |
| Unilateral Rib Fractures, Device Intervention | FEV1 Percent Change | 4.49 Percentage (%) | Standard Deviation 12.4 |
Primary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral Rib Fractures Only, no Device Intervention | FVC Change | 0.06 Liters (L) | Standard Deviation 0 |
| Unilateral Rib Fractures, Device Intervention | FVC Change | 0.34 Liters (L) | Standard Deviation 0.33 |
Secondary
Day of Admission
Documenting date and time of admission
Time frame: Within first 24 hours of admission
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unilateral Rib Fractures Only, no Device Intervention | Day of Admission | 1 Participants |
| Unilateral Rib Fractures, Device Intervention | Day of Admission | 2 Participants |
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.
Time frame: Documented within 2 weeks of admission date.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral Rib Fractures Only, no Device Intervention | Injury Severity Score | 9 score | Standard Deviation 0 |
| Unilateral Rib Fractures, Device Intervention | Injury Severity Score | 2.5 score | Standard Deviation 2.12 |
Secondary
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.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral Rib Fractures Only, no Device Intervention | Length of Stay | 2 Days | Standard Deviation 0 |
| Unilateral Rib Fractures, Device Intervention | Length of Stay | 4.5 Days | Standard Deviation 2.12 |
Secondary
Time to Ambulation
The initial time of ambulation documented after admission.
Time frame: 0-48 hours after admission.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral Rib Fractures Only, no Device Intervention | Time to Ambulation | 19.8 Hours | Standard Deviation 0 |
| Unilateral Rib Fractures, Device Intervention | Time to Ambulation | 22.75 Hours | Standard Deviation 3.46 |
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
Time frame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Unilateral Rib Fractures Only, no Device Intervention | Vital Capacity Measurement Via Incentive Spirometry | 0.20 Liters (L) | Standard Deviation 0 |
| Unilateral Rib Fractures, Device Intervention | Vital Capacity Measurement Via Incentive Spirometry | 0.95 Liters (L) | Standard Deviation 0.21 |