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

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.

Study Overview

• Status: Terminated
• Conditions: Rib Fractures; Rib Fracture Multiple
• Intervention / Treatment: Device: Chest 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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Colorado Springs, Colorado, United States, 80906
      • Penrose Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centura Health
• Investigators: Principal Investigator: Trenton Bradbury, BS, Centura Health

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Multiple Trauma; Fractures, Bone; Thoracic Injuries; Rib Fractures; Fractures, Multiple
• Other Study ID Numbers: 1517921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared. All information pertaining to statistical significance or lack thereof will be outlined in the final study publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes