Status:
TERMINATED
Flail Chest - Rib Fixation Study
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Synthes Inc.
Conditions:
Flail Chest
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether operative fixation of unilateral flail chest provides greater benefit than non-operative treatment.
Detailed Description
Chest trauma is frequent in the multiply-injured patient and is directly responsible for 20-25% of trauma deaths. Additionally, chest trauma is a major contributory factor in another 25% of deaths aft...
Eligibility Criteria
Inclusion
- 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
- 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.
- Any contra-indication to surgery including severe immunosuppression or severe chronic disease making elective surgery dangerous in the opinion of the surgeon
- Inability to proceed with any aspect of critical care due to personal beliefs, living will etc eg non acceptance of blood products
- Inability to obtain informed consent.
- Subject's refusal for follow up
- Pregnant women
- Prisoners
- Any other reason for which the potential subject is not a good candidate, in the opinion of the investigator.
- If the site investigator believes that a patient is a good candidate for the study (i.e. requires ventilation primarily due to altered chest wall mechanics) but fails to meet all criteria, site may contact Dr Ajai Malhotra to see if a waiver will be granted.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01147471
Start Date
September 1 2010
End Date
August 1 2014
Last Update
August 6 2015
Active Locations (7)
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1
Trauma Research & Education Foundation of Fresno
Fresno, California, United States, 93721
2
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
3
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
4
The Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104