Clinical trial NCT04909463: 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
Overall status: TERMINATED
Phase: NA
Conditions: Rib Fractures
Rib Fracture Multiple
Lead sponsor: CommonSpirit Health
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: FVC Change
timeFrame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
measure: FEV1 Change
timeFrame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
measure: FEV1 Percent Change
timeFrame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Secondary outcomes:
measure: Length of Stay
timeFrame: Documented at time of discharge, assessed up to 14 days.
measure: Time to Ambulation
timeFrame: 0-48 hours after admission.
measure: Injury Severity Score
timeFrame: Documented within 2 weeks of admission date.
measure: Day of Admission
timeFrame: Within first 24 hours of admission
measure: Vital Capacity Measurement Via Incentive Spirometry
timeFrame: 3 days of consistent measuring and a final measurement 24 hours prior to expected discharge
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Penrose Hospital
state: Colorado
Study officials:
affiliation: CommonSpirit Health
name: Trenton Bradbury, BS
role: PRINCIPAL_INVESTIGATOR
References: