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

Not Applicable

Terminated

Conditions: Rib Fractures
Rib Fracture Multiple

Interventions: Device: Chest Splint

Registration Number: NCT04909463

Lead Sponsor: CommonSpirit Health

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 8

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral rib fractures, device intervention	Chest Splint	Bilateral rib fractures, will receive device intervention
Unilateral rib fractures, device intervention	Chest Splint	Unilateral rib fractures, will receive device intervention

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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.
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
Time to Ambulation	0-48 hours after admission.	The initial time of ambulation documented after admission.
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