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

Primary Purpose

Rib Fractures, Rib Fracture Multiple

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chest Splint
Sponsored by
Centura Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penrose Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Arm Label

Unilateral rib fractures only, no device intervention

Unilateral rib fractures, device intervention

Bilateral rib fractures, no device intervention

Bilateral rib fractures, device intervention

Arm Description

Unilateral rib fractures only, no device intervention

Unilateral rib fractures, will receive device intervention

Bilateral rib fractures, no device intervention

Bilateral rib fractures, will receive device intervention

Outcomes

Primary Outcome Measures

FVC Change
Change in forced vital capacities over time using the device as compared to control groups
FEV1 Change
Change in forced expiratory volume in one second over hospital duration using the device as compared to control groups
FEV1 percent Change
Change in FEV1/FVC ratio (expressed as FEV1%) over hospital duration using the device as compared to control groups

Secondary Outcome Measures

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
Length of Stay
The length of stay for the entire admission to the time of discharge
Time to Ambulation
The initial time of ambulation documented 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.
Day of Admission
Documenting date and time of admission

Full Information

First Posted
January 4, 2021
Last Updated
March 10, 2022
Sponsor
Centura Health
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1. Study Identification

Unique Protocol Identification Number
NCT04909463
Brief Title
Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma
Official Title
Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Limited resources
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centura Health

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures, Rib Fracture Multiple

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unilateral rib fractures only, no device intervention
Arm Type
No Intervention
Arm Description
Unilateral rib fractures only, no device intervention
Arm Title
Unilateral rib fractures, device intervention
Arm Type
Experimental
Arm Description
Unilateral rib fractures, will receive device intervention
Arm Title
Bilateral rib fractures, no device intervention
Arm Type
No Intervention
Arm Description
Bilateral rib fractures, no device intervention
Arm Title
Bilateral rib fractures, device intervention
Arm Type
Experimental
Arm Description
Bilateral rib fractures, will receive device intervention
Intervention Type
Device
Intervention Name(s)
Chest Splint
Other Intervention Name(s)
Duracore
Intervention Description
Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
Primary Outcome Measure Information:
Title
FVC Change
Description
Change in forced vital capacities over time using the device as compared to control groups
Time Frame
3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Title
FEV1 Change
Description
Change in forced expiratory volume in one second over hospital duration using the device as compared to control groups
Time Frame
3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Title
FEV1 percent Change
Description
Change in FEV1/FVC ratio (expressed as FEV1%) over hospital duration using the device as compared to control groups
Time Frame
3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Secondary Outcome Measure Information:
Title
Vital Capacity measurement via Incentive Spirometry
Description
Change in vital capacity values indicating changes in deep breathing over the course of hospitalization while using the Duracore device
Time Frame
3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Title
Length of Stay
Description
The length of stay for the entire admission to the time of discharge
Time Frame
Documented at time of discharge, assessed up to 14 days.
Title
Time to Ambulation
Description
The initial time of ambulation documented after admission.
Time Frame
0-48 hours after admission.
Title
Injury Severity Score
Description
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.
Time Frame
Documented within 2 weeks of admission date.
Title
Day of Admission
Description
Documenting date and time of admission
Time Frame
Within first 24 hours of admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trenton Bradbury, BS
Organizational Affiliation
Centura Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be shared. All information pertaining to statistical significance or lack thereof will be outlined in the final study publication.

Learn more about this trial

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

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