Flail Chest - Rib Fixation Study

Not Applicable

Terminated

Conditions: Flail Chest

Interventions: Device: operative rib fixation
Procedure: operative rib fixation surgery

Registration Number: NCT01147471

Lead Sponsor: Virginia Commonwealth University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 24

Inclusion Criteria

Adults >21 years and <75 years
"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
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.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operative rib fixation	operative rib fixation surgery	Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm. Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.
Operative rib fixation	operative rib fixation	Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm. Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.

Primary Outcome Measures

Name	Time	Method
Mortality	Measured any time during hospital stay (approx 30 days)	Number of participants who died during any hospital stay.
Morbidity	Measured daily during hospitalization (approx 1 month)	total days on ventilator, ICU length of stay, hospital length of stay

Secondary Outcome Measures

Name	Time	Method
Quality of Life	Measured at 3 and 6 months post-discharge	Rand 36 health survey.
Pulmonary Function	Measured at 3 and 6 months post-discharge	Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1).

Trial Locations

Locations (7): Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States
The University of Tennessee
🇺🇸
Knoxville, Tennessee, United States
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
The Board of Regents of the University of Oklahoma
🇺🇸
Oklahoma City, Oklahoma, United States
Trauma Research & Education Foundation of Fresno
🇺🇸
Fresno, California, United States
Eastern Virginia Medical School
🇺🇸
Norfolk, Virginia, United States