Flail Chest - Rib Fixation Study



Status:Terminated
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:21 - 75
Updated:4/21/2016
Start Date:September 2010
End Date:August 2014

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Flail Chest: Early Operative Fixation Versus Non-operative Management - a Prospective Randomized Study

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

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 after trauma. Besides short term mortality, injuries to the chest
result in significant morbidity and cost of care and long term disability. Among patients
sustaining chest trauma, flail chest is one of the more serious injuries. Patients require
prolonged ventilation, ICU and hospital stays and have a high incidence of pulmonary
infections. Survivors often go on to have significant impairment of pulmonary function and
over half may never return to gainful employment.

The standard therapy of injuries to the chest wall, including flail chest has been effective
analgesia, pulmonary toilet with postural drainage and aggressive chest physical therapy.
Despite these measures, flail chest patients often do not do well. Early operative fixation
(surgical anchoring and bracing of bones) to stabilize the chest wall and restore pulmonary
dynamics has always been an attractive option. With improvements in patient selection,
availability of good modern anesthesia and critical care, and mechanical fixation devices,
small studies and several case reports testify to the feasibility of the concept and
possible short and long term benefits. All but one small institutional study are
retrospective in nature limiting the generalizability of the conclusions. In that small
single institutional prospective trial in which patients with flail chest were randomized to
either early operative fixation or standard non-operative therapy, patients randomized to
early operative fixation showed significant improvements in both short- and long-term health
outcomes resulting in lower in-hospital costs in the surgically treated group. Despite these
very impressive results, although prospective, it is one study with a small number of
patients from a single institution. The question of the benefits of operative fixation can
only be conclusively answered by a larger multi-institutional prospective randomized study.

Inclusion Criteria:

1. Adults >21 years and <75 years

2. "Stove-in chest" to encompass both

1. Unilateral flail chest (>3 ribs fractured at two places) or

2. Contiguous rib fractures with at least 2 ribs pushed in > the rib diameter of
the pushed in rib

3. Mechanically ventilated

Exclusion Criteria:

1. Patient unlikely to survive due to the trauma or age or multiple co-morbidities

2. Stove-in chest patients that do not require early (less than or equal to 48 hours of
injury) ventilatory support

3. Bilateral flail chest

4. Sternal flail

5. P/F ratio < 200:1 over a period of greater than or equal to 6 hours while on the
ventilator.

6. 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.

7. Any contra-indication to surgery including severe immunosuppression or severe chronic
disease making elective surgery dangerous in the opinion of the surgeon

8. Inability to proceed with any aspect of critical care due to personal beliefs, living
will etc eg non acceptance of blood products

9. Inability to obtain informed consent.

10. Subject's refusal for follow up

11. Pregnant women

12. Prisoners

13. 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.
We found this trial at
7
sites
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Fresno, CA
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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Norfolk, Virginia 23507
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Norfolk, VA
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Knoxville, Tennessee 37920
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Knoxville, TN
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Oklahoma City, OK
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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