Clinical trial NCT01147471: Flail Chest - Rib Fixation Study
Official title: Flail Chest: Early Operative Fixation Versus Non-operative Management - a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Flail Chest
Keywords: flail chest
rib fixation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Synthes Inc.
First posted: 2010-06-22
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Morbidity
timeFrame: Measured daily during hospitalization (approx 1 month)
measure: Mortality
timeFrame: Measured any time during hospital stay (approx 30 days)
Secondary outcomes:
measure: Quality of Life
timeFrame: Measured at 3 and 6 months post-discharge
measure: Pulmonary Function
timeFrame: Measured at 3 and 6 months post-discharge
Other outcomes:
measure: Still on Narcotics at Post-discharge Follow-up
timeFrame: approx 2 weeks post discharge
Locations:
city: Fresno
country: United States
facility: Trauma Research & Education Foundation of Fresno
state: California
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Oklahoma City
country: United States
facility: The Board of Regents of the University of Oklahoma
state: Oklahoma
city: Knoxville
country: United States
facility: The University of Tennessee
state: Tennessee
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Ajai K Malhotra, MD
role: PRINCIPAL_INVESTIGATOR
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