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

CommonSpirit Health

Status: Terminated

Conditions: Rib Fracture Multiple; Rib Fractures

Treatments: Device: Chest Splint

Study type: Interventional

Funder types: Other

Identifiers

NCT04909463

1517921

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 4 patient groups

Unilateral rib fractures only, no device intervention

No Intervention group

Description:

Unilateral rib fractures only, no device intervention

Unilateral rib fractures, device intervention

Experimental group

Description:

Unilateral rib fractures, will receive device intervention

Treatment:

Device: Chest Splint

Bilateral rib fractures, no device intervention

No Intervention group

Description:

Bilateral rib fractures, no device intervention

Bilateral rib fractures, device intervention

Experimental group

Description:

Bilateral rib fractures, will receive device intervention

Treatment:

Device: Chest Splint