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

Rib Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04909463
• Other study ID #: 1517921
• Status: Terminated
• Phase: N/A
• Start date: December 4, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: March 2022
• Source: Centura Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fracture Multiple
• Rib Fractures
• Thoracic Injuries

Intervention

Device:
• Chest Splint
Those receiving intervention will be given the Duracore chest splint for use throughout the trial.

Locations

Country	Name	City	State
United States	Penrose Hospital	Colorado Springs	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Centura Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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.
Secondary	Time to Ambulation	The initial time of ambulation documented after admission.	0-48 hours after admission.
Secondary	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.
Secondary	Day of Admission	Documenting date and time of admission	Within first 24 hours of admission