Flail Chest
Conditions
Keywords
flail chest, rib fixation
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.
Interventions
DEVICEoperative rib fixation
Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system.
PROCEDUREoperative rib fixation surgery
Sponsors
Synthes Inc.
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | Measured daily during hospitalization (approx 1 month) | total days on ventilator, ICU length of stay, hospital length of stay |
| Mortality | Measured any time during hospital stay (approx 30 days) | Number of participants who died during any hospital stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Still on Narcotics at Post-discharge Follow-up | approx 2 weeks post discharge | Number of people still on narcotics at time of routine care post-discharge follow-up |
Countries
United States
Participant flow
Recruitment details
Adult patients, 21 to 75 years old, admitted to the trauma unit with injuries that include either stove in chest (contiguous rib fractures with at least 2 ribs pushed in a distance greater than the rib diameter of the pushed in rib) or a unilateral flail chest (3 or more ribs fractures at two places). Patients must be on a ventilator.
Participants by arm
| Arm | Count |
|---|---|
| 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.
operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system. | 13 |
| Non-operative Arm Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):
a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry - after extubation. | 11 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3 Month Follow Up | Lost to Follow-up | 1 | 1 |
| 3 Month Follow Up | Physician Decision | 0 | 1 |
| 6 Month Follow Up | Lost to Follow-up | 4 | 2 |
| Post-discharge Follow Up (Approx 2 Wks) | incarcerated | 0 | 1 |
| Post-discharge Follow Up (Approx 2 Wks) | Lost to Follow-up | 0 | 1 |
| Post-discharge Follow Up (Approx 2 Wks) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Non-operative Arm | Operative Rib Fixation |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 11 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 4 Participants | 4 Participants |
| Mechanism of injury Fall from height | 1 participants | 0 participants | 1 participants |
| Mechanism of injury Motor cycle crash | 7 participants | 5 participants | 2 participants |
| Mechanism of injury Motor vehicle crash | 12 participants | 5 participants | 7 participants |
| Mechanism of injury Pedestrian struck | 4 participants | 1 participants | 3 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) White | 13 Participants | 6 Participants | 7 Participants |
| Region of Enrollment United States | 24 participants | 11 participants | 13 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 20 Participants | 10 Participants | 10 Participants |
| Side & position of flail Antero-lateral | 5 participants | 2 participants | 3 participants |
| Side & position of flail left side flail | 10 participants | 4 participants | 6 participants |
| Side & position of flail Postero-lateral | 19 participants | 9 participants | 10 participants |
| Side & position of flail right side flail | 14 participants | 7 participants | 7 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 11 |
| serious Total, serious adverse events | 0 / 13 | 2 / 11 |
Outcome results
Primary
Morbidity
total days on ventilator, ICU length of stay, hospital length of stay
Time frame: Measured daily during hospitalization (approx 1 month)
Population: analysis is the mean and standard deviation for # days spent on each item measured
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Operative Rib Fixation | Morbidity | days on ventilator | 12.6 days | Standard Deviation 8.5 |
| Operative Rib Fixation | Morbidity | days in ICU | 23.1 days | Standard Deviation 20.3 |
| Operative Rib Fixation | Morbidity | days in hospital | 27.4 days | Standard Deviation 18.7 |
| Non-operative Arm | Morbidity | days on ventilator | 7.0 days | Standard Deviation 4.2 |
| Non-operative Arm | Morbidity | days in ICU | 13.0 days | Standard Deviation 6.1 |
| Non-operative Arm | Morbidity | days in hospital | 20.8 days | Standard Deviation 8.8 |
Primary
Mortality
Number of participants who died during any hospital stay.
Time frame: Measured any time during hospital stay (approx 30 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Operative Rib Fixation | Mortality | 0 participants |
| Non-operative Arm | Mortality | 0 participants |
Secondary
Pulmonary Function
Pulmonary function tests to measure forced vital capacity (FVC) and forced expiratory volume one (FEV1).
Time frame: Measured at 3 and 6 months post-discharge
Population: Data not collected - insufficient participants completed follow up visits
Secondary
Quality of Life
Rand 36 health survey.
Time frame: Measured at 3 and 6 months post-discharge
Population: Data not collected - insufficient participants completed follow up visits
Other Pre-specified
Still on Narcotics at Post-discharge Follow-up
Number of people still on narcotics at time of routine care post-discharge follow-up
Time frame: approx 2 weeks post discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Operative Rib Fixation | Still on Narcotics at Post-discharge Follow-up | 7 participants |
| Non-operative Arm | Still on Narcotics at Post-discharge Follow-up | 6 participants |