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

NCT04909463 | Terminated Results DMC

• 1 other identifier: 1517921
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures; Rib Fracture Multiple

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Length of Stay

  Documented at time of discharge, assessed up to 14 days.

• Time to Ambulation

  0-48 hours after admission.

• Injury Severity Score

  Documented within 2 weeks of admission date.

• Day of Admission

  Within first 24 hours of admission

• Vital Capacity Measurement Via Incentive Spirometry

  3 days of consistent measuring and a final measurement 24 hours prior to expected discharge

Study Arms (4)

Unilateral rib fractures only, no device intervention

NO INTERVENTION

Unilateral rib fractures only, no device intervention

Unilateral rib fractures, device intervention

EXPERIMENTAL

Unilateral rib fractures, will receive device intervention

Device: Chest Splint

Bilateral rib fractures, no device intervention

NO INTERVENTION

Bilateral rib fractures, no device intervention

Bilateral rib fractures, device intervention

EXPERIMENTAL

Bilateral rib fractures, will receive device intervention

Device: Chest Splint

Interventions

Chest Splint DEVICE

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

Also known as: Duracore

Bilateral rib fractures, device intervention; Unilateral rib fractures, device intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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

Sponsors & Collaborators

• CommonSpirit Health: lead

Study Sites (1)

Penrose Hospital

Colorado Springs, Colorado, 80906, United States

Location

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Limitations and Caveats

Early termination due to subject unavailability due to the COVID-19 pandemic. Uninterpretable data.

Results Point of Contact

• Title: Trenton Bradbury
• Organization: CommonSpiritHealth

trenton_b1@yahoo.com

7193730213

Study Officials

• Trenton Bradbury, BS

  CommonSpirit Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Respiratory Therapist

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: June 1, 2021
• Study Start: December 4, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: May 14, 2025
• Results First Posted: May 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)