Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma

Conditions
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Rib Fractures, Rib Fracture Multiple

Intervention / Treatment
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* Device: Chest Splint


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Unilateral rib fractures only, no device intervention<br>Unilateral rib fractures only, no device intervention | |
| Experimental: Unilateral rib fractures, device intervention<br>Unilateral rib fractures, will receive device intervention | Device: Chest Splint<br>* Those receiving intervention will be given the Duracore chest splint for use throughout the trial.<br>* Other names: Duracore;|
| No Intervention: Bilateral rib fractures, no device intervention<br>Bilateral rib fractures, no device intervention | |
| Experimental: Bilateral rib fractures, device intervention<br>Bilateral rib fractures, will receive device intervention | Device: Chest Splint<br>* Those receiving intervention will be given the Duracore chest splint for use throughout the trial.<br>* Other names: Duracore;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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. | 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 |