Effects of Using the Duracore Splinting Device on Patient Outcomes Related to Chest Trauma
Phase: NA
Conditions: Rib Fractures, Rib Fracture Multiple
Sponsor: CommonSpirit Health

 
 
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Protocol Version Date: November 17, 2019  
 
Title: Effects of using the Duracore Splinting Device on Patient 
Outcomes Related to Chest Trauma 
Protocol Version Number: 3         
Protocol Version Date: 12/8/2020 
CHIRB IRBNet ID:  1517921-3 
1) 
Investigators 
 
Principal Investigator 
Trenton Bradbury 
Title: Registered Respiratory Therapist 
Department: Respiratory Therapy 
Phone Number: (719)-373-0213 
Email: trentonbarnett@centura.org 
 
Co-Investigator:    
Matt Sturtevant 
Title: Registered Respiratory Therapist 
Department: Respiratory Therapy 
Phone Number: (719)-250-3187 
Email: mandlsturtevant@gmail.com 
 
Co-Investigator:    
Joanne Armstrong 
Title: Registered Respiratory Therapist 
Department: Respiratory Therapy 
Phone Number: (505)-603-2064 
Email: joannearmstrong2@centura.org 
 
Co-Investigator: 
Dr. Allen Tanner II, M.D. 
Title: Surgical Trauma Physician 
Department: Trauma Services 
Email: ahtannerii@gmail.com 
 
2) 
Funding Source 
Financial funding was obtained by grants from local agencies through 
application processes, along with interviews and assessment of the medical 
device. The first grant was obtained through the Southern Colorado Society 
of Respiratory Care in hopes to obtain better choices for treatment for 
patients with rib fractures. Additional funding was provided by the Penrose 
Foundation as well. 

 
 
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Protocol Version Date: November 17, 2019  
3) 
Objectives and Hypothesis(es) 
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 force vital capacity 
(FVC) and FEV1 tests. 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.  
4) 
Background/Scientific Rationale and Significance 
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 percent predicted 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. 
5) 
Inclusion and Exclusion 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 ages 18 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 >5 years 
 Diagnosis of flail chest 

 
 
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Protocol Version Date: November 17, 2019  
 Pregnant Women 
 Prisoners 
 Cognitively Impaired; must be alert and oriented x 3 
 
6) 
Number of Subjects 
Number of subjects was based on a power analysis using FVC/FEV1 as the primary 
variable and stratified by unilateral versus bilateral diagnosis. Previous literature 
suggests a standard deviation of approximately 0.20-0.60 for FVC/FEV1 values. SD 
was set at 0.40. Unilateral control was estimated to be 50% of predicted values 
(FVC/FEV1) due to the nature of the injury, set at approximately 1.50L, with 
bilateral set at approximately 1.35L. Unilateral experimental group means were 
increased by 20% of predicted values to 1.80L, and bilateral to 1.50L. The required 
sample size to achieve 80% power to detect difference between splint and control 
groups is 104, with each group requiring 26 subjects each. Power calculations were 
performed in R version 4.0.0 with the pwr2ppl package, using the anova2x2 
function.  
Number of subjects to be used are 150 to account for withdrawals, incomplete data 
sets, extraneous results, etc. This is a single site study. 
7) 
Recruitment Methods 
Respiratory Therapy is part of the trauma multi-disciplinary team. and is involved 
with the care of every trauma patient admitted to Penrose Hospital. During trauma 
rounds in the ICU and floor patients that met criteria for the study will be identified. 
The investigators will approach those identified patients for potential enrollment in 
the study. Note they will not approach any patient for consent that is under their 
care that shift. There are no flyers or advertisements for this research or device. 
8) 
Study Timelines 
It is estimated that it will take at least one year to complete this study to include 
enrollment, subject completion, and all analysis.  All primary variables and analyses 
should be completed by this time. 
 
9) 
Study Endpoints 
The primary endpoint of this study is to investigate the use of the Duracore 
splinting device in patients with chest trauma. Hospital length of stays, time to 
ambulation, a patient satisfaction survey, incentive spirometry, forced vital capacity 
measurements, and the injury severity score will be correlated to a control group to 
determine its’ effectiveness. The quantitative data points will be collected over the 
first three days of hospital stay and 24 hours prior to discharge. The qualitative data 
will be collected prior to patient discharge. 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. 
Variables to be collected are: 
 Age (years) 
 Gender 
 Diagnosis 

 
 
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Protocol Version Date: November 17, 2019  
 Incentive Spirometry values for this admission 
 FVC/FEV1 values for this admission 
 Height, Weight, and Ethnicity for FVC/FEV1 % predicted calculation 
 Averages from the patient satisfaction survey using a Likert Scale 
 Length of Stays 
 Time to Ambulation 
 Injury Severity Score 
10) Procedures Involved 
The design of this study is a randomized experimental trial. The procedures 
involved in this study will first include obtaining the individual’s consent to 
participate. Incentive spirometry is a standard of care that has been proven to 
improve deep breathing for patients. FVC/FEV1 measurements are not always 
routinely done at this site but has been proven to be an indicator in respiratory 
deterioration in this population. Enrollment of each subject will be on a one to one 
basis for control and experimental groups. The trial will be randomized to reduce 
bias by randomly selecting patients between control and experimental groups by 
alternating every other patient receiving the treatment. Height, sex, ethnicity, and 
age will be accounted for as well to calculate the percent predicted FVC/FEV1 to 
reduce statistical error. Enrollment will be based on patient consent. After 
enrollment into the study after admission to the hospital, baseline values of 
incentive spirometry (IS) and spirometry will be done. The patient will then be 
placed in the experimental or control group after being assigned a group via 
envelope randomization. If the patient is under experimental, they will receive a 
splinting device for treatment. Control groups will receive standard of care 
treatment without the splinting device. Continued analysis of IS and FVC/FEV1 will 
occur over three days, and a final collection prior to discharge. Discharge planning 
will be coordinated with respiratory therapy, so the patient does not go home 
without completing the survey and final analysis. The patient satisfaction survey 
will be a paper survey administered to the patient. Patient identifying information 
will not be present on this form to maintain confidentiality. The patient will be 
asked if they would like to complete the form and that it is an anonymous short 
survey to help with identifying how the patient felt about the research. The subject 
will only be enrolled in the study for the duration of their hospital stay as an in-
patient. There will be no follow-up after discharge, and any patients who are 
discharged without completing the final analysis will be omitted from the study. 
 
11) Data Analysis Plan 
Data analysis will include a two-tailed t-test to account for significance between 
control and experimental groups. This will be done with both incentive spirometry 
and FVC/FEV1. Correlations will be made with time to ambulation and length of 
stays, as well as injury severity score. Graphic representation of trends will also be 
used to demonstrate differences between the groups. Qualitative analysis will 
include providing averages from the questionnaire using a Likert scale. These 
averages will be used to determine whether the population felt the device provided 
any help with their chest trauma. Number of subjects was based on a power analysis 

 
 
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Protocol Version Date: November 17, 2019  
using FVC/FEV1 as the primary variable. Previous literature suggests a standard 
deviation of approximately 0.20-0.60 for FVC/FEV1 values. SD was set at 0.40. 
Unilateral control was estimated to be 50% of predicted values (FVC/FEV1) due to 
the nature of the injury, set at approximately 1.50L, with bilateral set at 
approximately 1.35L. Unilateral experimental group means were increased by 20% 
of predicted values to 1.80L, and bilateral to 1.50L. The required sample size to 
achieve 80% power to detect difference between splint and control groups is 104, 
with each group requiring 26 subjects each. Power calculations were performed in 
R version 4.0.0 with the pwr2ppl package, using the anova2x2 function.  
Number of subjects to be used are 150 to account for withdrawals, incomplete data 
sets, extraneous results, etc. This is a single site study. 
Patient satisfaction surveys will use a numbered Likert Scale. The averages 
of each answer will be used to reinforce the efficacy of the device and 
correlate to primary data. Randomization will occur by experimenter-
blinded envelope randomization. 
 
12) Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
Subjects will be monitored for the duration of their stay by all staff members, and 
any adverse events related to the device itself will be reported accordingly. This 
device claims minimal risk to patients due to its unrestrictive and non-invasive 
nature but will be monitored by investigators for any adverse effects. The Data 
Safety Monitoring staff will review all documentation accordingly at least 
quarterly. 
13) Withdrawal of Subjects 
Subjects may voluntarily withdraw from the study at any time during their 
admission. Subjects may be withdrawn from the study if they are discharged 
prior to final analysis, deterioration of health rendering them incapable of 
participating in research, or verbal authorization to remove them from the 
study. Subjects may be removed in the case that the protocol needs to be 
revised due to an unforeseen adverse event that would exclude them from 
the study. All data will be retained unless specified by the subject up to the 
required date. 
14) Risks to Subjects 
The risk to subjects is extremely minimal. Chest trauma is consistently treated with 
incentive spirometry and monitored with FVC/FEV1 percent predicted values. 
There is very little risk to the patient with these procedures, and only some 
discomfort and pain from the rib fractures may be associated. The difference is the 
addition of the splinting device. Splinting devices are routinely used in the hospital 
for open heart patients and produces no associated risk to those patients. It is 
unlikely that this splinting device will produce any adverse events. The device is 
unrestrictive and only splints the chest when the patient wants it to. The only 

 
 
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Protocol Version Date: November 17, 2019  
potential risks are some discomfort, and an unknown allergy to the urethane coated 
polyester fabric on the device. 
15) Potential Benefits to Subjects 
Potential benefits to the subjects are unknown currently. 
 
16) Sharing of Results with Subjects 
Specific study results will not be shared with subjects 
17) Setting 
Potential subjects will be recruited at Penrose Hospital in Colorado Springs, 
CO.  
18) Resources Available 
Research staff oversee enrollment and follow-up of subjects throughout their 
hospital stay. They are responsible for data collection and retention, as well 
as education of secondary hospital staff that will be seeing the device. The 
respiratory therapy department will perform the procedures because they are 
a standard of care. The department will not be directly involved in this 
research activity and will only be performing normal ordered procedures 
with the patients. All staff performing procedures are board certified and 
state-licensed respiratory therapists, and it is within their scope of practice to 
perform these procedures. This includes investigating staff. Nursing staff 
will also reinforce incentive spirometry use, which is a standard of care. 
Investigators will be the only people to be collecting relevant data from the 
chart. All relevant staff in the hospital will be educated on what the device is 
by investigators to better introduce the device into the work environment. 
Should it be necessary, the hospital is a place of availability for any medical 
or psychological need during the subjects’ length of stay. This is the site in 
which all procedures and experimental data will be collected. 
Penrose Hospital is a level I verified trauma center and receives patients 
with rib fractures and pulmonary contusions regularly. The sample size is 
justified statistically and is relevant to account for withdrawals. The actual 
sample size only needs to be 70% of the specified 150 to provide 
statistical significance. 

 
 
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Protocol Version Date: November 17, 2019  
19) Prior Approvals 
The Duracore chest splint was presented at the trauma-research meeting May 2, 
2019. Approval was granted for trial of the device pending modification of the 
device to include a removable shell for trial phase. Received financial assistance 
through approval of application process from the Southern Colorado Society of 
Respiratory Care for the Duracore chest splint for trial. 
20) Confidentiality 
Data will be protected by keeping it within the hospital system. All forms, online 
forms, EPIC data, etc. will be kept in the respiratory therapy department behind a 
locked door requiring a code. All other data will be kept in the hospital system’s 
computer for security and HIPPA purposes and will not be removed from the site 
by personnel. Investigators will only have access to the data intended for 
interpretation, but all other data will be available on EPIC for viewing from relevant 
staff. Data will be retained within the system for at least three years. The protocol 
will follow all requirements as listed by CHI Research Data Security. 
21) Provisions to Protect the Privacy Interests of Subjects 
Should there be a desire to place a limit on whom the subject interacts 
with or provides personal information to, accommodations will be made to 
ensure they are comfortable. Subjects should always feel at ease and all 
questions regarding the research will be directed in a friendly, caring, and 
ethically sound manner. The research team is only permitted to have 
access to relevant information that pertains to the research, unless 
otherwise specified by the individual. 
22) Compensation for Research-Related Injury 
Subjects will not be compensated for participating in this study. 
23) Economic Burden to Subjects 
This study will not change the cost to the subjects. All tests are a part of a 
standard of care and will therefore be included in their hospital stay. The 
Duracore splinting device is not paid for by the hospital or subject, but by 
the sponsors. The splinting device is not sent home with the subject. 

 
 
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Protocol Version Date: November 17, 2019  
24) Consent Process 
Written consent will be obtained from the subject prior to inclusion into the study. 
This study is minimal risk because it involves standards of care with the addition of 
a minimal risk device. Consent will take place when the patient is admitted to the 
hospital and in a room. The participant will be told of the research design, intended 
outcome, the role of the device, any associated risks, discomfort, or allergies. Any 
necessary amount of time will be dedicated to the consenting process so that the 
participant has reached a full and complete understanding. Inclusion specifics will 
be followed to ensure all coercion and undue influence is avoided. No potential 
subject unable to make their own decisions will be enrolled in the study. 
Non-English-Speaking Subjects: 
The primary non-English speaking subject will be Spanish in this region. 
The hospital has access to translators that can translate for a patient if this 
were to be necessary. A short form will be used to obtain consent if a non-
English speaking patient is enrolled in the study.   
Cognitively Impaired Adults/Temporary or Permanent Lack of Capacity 
to Provide Informed Consent 
The process to determine whether an individual can give verbal consent 
will be conducted by determining if they are oriented to person, place, and 
time. If this changes after enrollment and the patient is unable to make 
decisions for themselves, the dedicated medical power of attorney for that 
patient will be consulted. The use of this device requires intact cognition 
and may cause them to be omitted from the study in this case. 
 
25) Process to Document Consent in Writing 
Informed consent will be obtained in the patient room within the first 24 hours of 
admission. This will be a paper consent form and will be signed by the subject if the 
subject decides to be included in the study. All inclusion criteria must be met. The 
informed consent follows the CIRI template and outlines all procedures and risks 
associated with the study. Informed consent will be retained for the duration of the 
study and thereafter in accordance with regulations. Please see the informed consent 
for all information given to the patient.  
26) Drugs or Devices 
The splinting device will be primarily made of a urethane coated polyester 
fabric with anti-microbial additives which is soft, pliable, and stretchable. 
The device will be stored within the respiratory therapy equipment storage 
room at Penrose hospital and the research team will be notified by the 
Trauma team or respiratory therapy when a subject is admitted to the 
hospital who meets inclusion criteria for the study. 
The FDA was contacted regarding the IDE Approval Process. Based on 
the response from the encounter with the FDA, that during the approval 
process with the IRB, the governing body of the IRB would deem the 
device as Significant or Non-Significant. The claim of the Duracore 

 
 
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Protocol Version Date: November 17, 2019  
splinting device is to be non-significant device. It is low risk and does not 
present potential for serious risk to the health, safety, or welfare of a 
subject. FDA recommendations are being followed to label the device 
accordingly. A nonsignificant risk device study requires only IRB 
approval prior to initiation of a clinical study. Sponsors of studies 
involving nonsignificant risk devices are not required to submit an IDE 
application to the FDA for approval per FDA regulations.  
The plan is to comply with the abbreviated IDE requirements under 
§812.2 (b):  
· The device will be labeled with “CAUTION – Investigational Device. 
Limited by Federal (or United States) law to investigational use.”  
· This is the current label for the device  
 
· Will monitor for any adverse effects daily with subjects using the device 
33)  Other Requirements 
REGULATORY, ETHICAL AND LEGAL OBLIGATIONS 
Institutional Review Boards/Ethics Committees 
 
Before implementing this study, the protocol and all associated documents must 
be reviewed by a properly constituted committee or committees responsible for 
approving clinical studies.  The IRB’s written, signed approval letter must contain 
approval of the designated investigator(s) and the protocol (identifying protocol title, date 
and version number). 
 
Any change or addition to the protocol can only be made in a written protocol 
amendment that must be approved by the responsible party and the local IRB. 
Patient Confidentiality and Disclosure 
 
Data on patients collected on eCRFs during the trial will be documented in an 
anonymous fashion and the patient will only be identified by the patient enrollment 
number, and by his/her initials. If, as an exception, it is necessary for regulatory reasons 
to identify the patient, all parties are bound to keep this information confidential. 
 
The investigator will guarantee that all persons involved will respect the 
confidentiality of any information concerning the study patients. All parties involved in 
the study will maintain strict confidentiality to assure that neither the person nor the 
family privacy of a patient participating in the trial is violated.  Likewise, the appropriate 
measures shall be taken to prevent access of non-authorized persons to the study data. 

 
 
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Collection, Monitoring and Auditing Study Documentation, and Storage 
Collection of Data and Monitoring Procedures 
 
This study will use an electronic data capture system (eDC). A paper case report 
form (CRF) is used for data recording.  All data requested on the CRF must be entered 
and all missing data must be accounted for. 
 
The data will be checked for completeness and correctness as it is entered by the 
real-time online checks applied by the eDC system. Off-line checks will also be run to 
perform any additional data review required.  Discrepancy reports will be generated 
accordingly and transferred to the study center for resolution by the investigator or 
his/her designee. 
Auditing Procedure 
 
In addition to the routine monitoring procedures, the regulatory authority can 
conduct an audit or an inspection (during the study or after its completion) to evaluate 
compliance with the protocol and the principles of Good Clinical Practice. The 
investigator agrees that representatives of the Regulatory Authorities will have direct 
access, both during and after the course of this study, to audit and review all study-
relevant medical records. 
Retention of Documents 
 
The investigator must maintain source documents for each patient in the study, 
consisting of all demographic and medical information, including efficacy assessments. 
All information on case report forms must be traceable to these source documents in the 
patient's file. No data will be without a written or electronic record. 
Disclosure of Information 
 
No disclosure shall be made except in accordance with a right of publication 
granted to the investigator. No information about this study or its progress will be 
provided to anyone not involved in the study other than Trauma Research, LLC or its 
authorized representatives, or in confidence to the IRB except if required by law. 
Study Report, Publication Policy and Archiving of Study Documentation 
Study Report and Publication Policy 
 
An integrated clinical and statistical report will be prepared upon completion of 
the study and data analysis.  The results of the study will be published in a relevant peer-
reviewed journal, with authorship status and ranking designated according to the 
acknowledged contributions of participating investigators, institutions. 
Archiving of Documents 
 
Essential documents, as listed below, must be retained by the investigator for as 
long as needed to comply with national and international regulations. The investigator 

 
 
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Protocol Version Date: November 17, 2019  
agrees to adhere to the document retention procedures by signing the protocol.  Essential 
documents include: 
IRB/IEC/REB approvals for the study protocol and all amendments 
All source documents  
CRF copies  
Any other pertinent study document.