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

NCT ID: NCT04909463

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-04
• Study Completion Date: 2021-07-30

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.

Conditions

Rib Fractures; Rib Fracture Multiple

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Unilateral rib fractures only, no device intervention

Unilateral rib fractures only, no device intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Unilateral rib fractures, device intervention

Unilateral rib fractures, will receive device intervention

Group Type: EXPERIMENTAL

Chest Splint

Intervention Type: DEVICE

Those receiving intervention will be given the Duracore chest splint for use throughout the trial.

Bilateral rib fractures, no device intervention

Bilateral rib fractures, no device intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Bilateral rib fractures, device intervention

Bilateral rib fractures, will receive device intervention

Group Type: EXPERIMENTAL

Chest Splint

Intervention Type: DEVICE

Those receiving intervention will be given the Duracore chest splint for use throughout the trial.

Interventions

Chest Splint

Those receiving intervention will be given the Duracore chest splint for use throughout the trial.

Intervention Type: DEVICE

Other Intervention Names

Duracore

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CommonSpirit Health

OTHER

Sponsor Role: lead

Responsible Party

Trenton Bradbury

Registered Respiratory Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trenton Bradbury, BS

Role: PRINCIPAL_INVESTIGATOR

CommonSpirit Health

Locations

Penrose Hospital

Colorado Springs, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1517921

Identifier Type: -

Identifier Source: org_study_id