TerminatedNot Applicable

Flail Chest - Rib Fixation Study

Stopped: Insufficient enrollment

United States24 participantsStarted 2010-09

Plain-language summary

The purpose of this study is to determine whether operative fixation of unilateral flail chest provides greater benefit than non-operative treatment.

Who can participate

Age range

21 Years – 75 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 criteria

. Adults \>21 years and \<75 years
. "Stove-in chest" to encompass both
. Unilateral flail chest (\>3 ribs fractured at two places) or
. Contiguous rib fractures with at least 2 ribs pushed in \> the rib diameter of the pushed in rib
. Mechanically ventilated

Exclusion criteria

. Patient unlikely to survive due to the trauma or age or multiple co-morbidities
. Stove-in chest patients that do not require early (less than or equal to 48 hours of injury) ventilatory support
. Bilateral flail chest
. Sternal flail
. P/F ratio \< 200:1 over a period of greater than or equal to 6 hours while on the ventilator.
. Other injuries that will likely prolong tracheal intubation and mechanical ventilation eg significant head injury resulting in low GCS (Glasgow Coma Score, a scale used to assess the central nervous system in patients who have undergone trauma), spinal cord injury resulting in paralysis of some or all of the respiratory muscles etc. These are merely examples. It is in the opinion of the investigator/surgeon what injuries would prolong tracheal intubation.

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

Morbidity

Timeframe: Measured daily during hospitalization (approx 1 month)

Mortality

Timeframe: Measured any time during hospital stay (approx 30 days)

Trial details

NCT IDNCT01147471

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-08

Results submitted2015-08-04

View on ClinicalTrials.gov More Flail Chest trials