TerminatedNot Applicable

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

Stopped: Limited resources

United States8 participantsStarted 2020-12-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

FVC Change

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

FEV1 Change

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

FEV1 Percent Change

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

Trial details

NCT IDNCT04909463

SponsorCommonSpirit Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-30

Results submitted2024-07-11

View on ClinicalTrials.gov More Rib Fractures trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

FVC Change

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

FEV1 Change

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

FEV1 Percent Change

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