Flail Chest - Rib Fixation Study

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.

Study Overview

• Status: Terminated
• Conditions: Flail Chest
• Intervention / Treatment: Device: operative rib fixation; Procedure: operative rib fixation surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93721
      • Trauma Research & Education Foundation of Fresno
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • The Board of Regents of the University of Oklahoma
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • The University of Tennessee
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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.; Procedure: operative rib fixation surgery
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Still on Narcotics at Post-discharge Follow-up	Number of people still on narcotics at time of routine care post-discharge follow-up	approx 2 weeks post discharge

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Synthes Inc.
• Investigators: Principal Investigator: Ajai K Malhotra, MD, Virginia Commonwealth University

Publications and helpful links

General Publications

• Nirula R, Allen B, Layman R, Falimirski ME, Somberg LB. Rib fracture stabilization in patients sustaining blunt chest injury. Am Surg. 2006 Apr;72(4):307-9. doi: 10.1177/000313480607200405.
• Baker CC, Oppenheimer L, Stephens B, Lewis FR, Trunkey DD. Epidemiology of trauma deaths. Am J Surg. 1980 Jul;140(1):144-50. doi: 10.1016/0002-9610(80)90431-6.
• Shorr RM, Mirvis SE, Indeck MC. Tension pneumopericardium in blunt chest trauma. J Trauma. 1987 Sep;27(9):1078-82. doi: 10.1097/00005373-198709000-00021.
• LoCicero J 3rd, Mattox KL. Epidemiology of chest trauma. Surg Clin North Am. 1989 Feb;69(1):15-9. doi: 10.1016/s0039-6109(16)44730-4.
• Shackford SR, Smith DE, Zarins CK, Rice CL, Virgilio RW. The management of flail chest. A comparison of ventilatory and nonventilatory treatment. Am J Surg. 1976 Dec;132(6):759-62. doi: 10.1016/0002-9610(76)90453-0.
• Relihan M, Litwin MS. Morbidity and mortality associated with flail chest injury: a review of 85 cases. J Trauma. 1973 Aug;13(8):663-71. doi: 10.1097/00005373-197308000-00001. No abstract available.
• Landercasper J, Cogbill TH, Lindesmith LA. Long-term disability after flail chest injury. J Trauma. 1984 May;24(5):410-4. doi: 10.1097/00005373-198405000-00007.
• Sankaran S, Wilson RF. Factors affecting prognosis in patients with flail chest. J Thorac Cardiovasc Surg. 1970 Sep;60(3):402-10. No abstract available.
• Menard A, Testart J, Philippe JM, Grise P. Treatment of flail chest with Judet's struts. J Thorac Cardiovasc Surg. 1983 Aug;86(2):300-5.
• Paris F, Tarazona V, Blasco E, Canto A, Casillas M, Pastor J, Paris M, Montero R. Surgical stabilization of traumatic flail chest. Thorax. 1975 Oct;30(5):521-7. doi: 10.1136/thx.30.5.521.
• Thomas AN, Blaisdell FW, Lewis FR Jr, Schlobohm RM. Operative stabilization for flail chest after blunt trauma. J Thorac Cardiovasc Surg. 1978 Jun;75(6):793-801. No abstract available.
• Landreneau RJ, Hinson JM Jr, Hazelrigg SR, Johnson JA, Boley TM, Curtis JJ. Strut fixation of an extensive flail chest. Ann Thorac Surg. 1991 Mar;51(3):473-5. doi: 10.1016/0003-4975(91)90871-m.
• Engel C, Krieg JC, Madey SM, Long WB, Bottlang M. Operative chest wall fixation with osteosynthesis plates. J Trauma. 2005 Jan;58(1):181-6. doi: 10.1097/01.ta.0000063612.25756.60. No abstract available.
• Lardinois D, Krueger T, Dusmet M, Ghisletta N, Gugger M, Ris HB. Pulmonary function testing after operative stabilisation of the chest wall for flail chest. Eur J Cardiothorac Surg. 2001 Sep;20(3):496-501. doi: 10.1016/s1010-7940(01)00818-1.
• Ahmed Z, Mohyuddin Z. Management of flail chest injury: internal fixation versus endotracheal intubation and ventilation. J Thorac Cardiovasc Surg. 1995 Dec;110(6):1676-80. doi: 10.1016/S0022-5223(95)70030-7.
• Voggenreiter G, Neudeck F, Aufmkolk M, Obertacke U, Schmit-Neuerburg KP. Operative chest wall stabilization in flail chest--outcomes of patients with or without pulmonary contusion. J Am Coll Surg. 1998 Aug;187(2):130-8. doi: 10.1016/s1072-7515(98)00142-2.
• Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.
• Bastos R, Calhoon JH, Baisden CE. Flail chest and pulmonary contusion. Semin Thorac Cardiovasc Surg. 2008 Spring;20(1):39-45. doi: 10.1053/j.semtcvs.2008.01.004.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 7, 2010
• First Submitted That Met QC Criteria: June 17, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Estimate): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: flail chest; rib fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Flail Chest
• Other Study ID Numbers: VCU-20100582

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No