Flail Chest - Rib Fixation Study

NCT01147471 | Terminated Results DMC

• 1 other identifier: VCU-20100582
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Flail Chest

Keywords

flail chest; rib fixation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Quality of Life

  Measured at 3 and 6 months post-discharge

• Pulmonary Function

  Measured at 3 and 6 months post-discharge

Other Outcomes (1)

• Still on Narcotics at Post-discharge Follow-up

  approx 2 weeks post discharge

Study Arms (2)

Operative rib fixation

ACTIVE COMPARATOR

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; Procedure: operative rib fixation surgery

Non-operative arm

NO INTERVENTION

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.

Interventions

operative rib fixation DEVICE

Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system.

Operative rib fixation

operative rib fixation surgery PROCEDURE

Operative rib fixation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>21 years and \<75 years
• "Stove-in chest" to encompass both
• Unilateral flail chest (\>3 ribs fractured at two places) or
• Contiguous rib fractures with at least 2 ribs pushed in \> the rib diameter of the pushed in rib
• Mechanically ventilated

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Synthes Inc.: collaborator

Study Sites (7)

Trauma Research & Education Foundation of Fresno

Fresno, California, 93721, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

The Board of Regents of the University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

The University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (18)

• 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.

  PMID: 16676852 BACKGROUND

• 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.

  PMID: 7396078 BACKGROUND

• 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.

  PMID: 3656472 BACKGROUND

• 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.

  PMID: 2911786 BACKGROUND

• 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.

  PMID: 998864 BACKGROUND

• 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.

  PMID: 4720987 BACKGROUND

• 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.

  PMID: 6716518 BACKGROUND

• 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.

  PMID: 5271286 BACKGROUND

• 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.

  PMID: 6876866 BACKGROUND

• 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.

  PMID: 1105874 BACKGROUND

• 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.

  PMID: 661347 BACKGROUND

• 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.

  PMID: 1998429 BACKGROUND

• 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.

  PMID: 15674171 BACKGROUND

• 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.

  PMID: 11509269 BACKGROUND

• 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.

  PMID: 8523879 BACKGROUND

• 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.

  PMID: 9704957 BACKGROUND

• 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.

  PMID: 11956391 BACKGROUND

• 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.

  PMID: 18420125 BACKGROUND

MeSH Terms

Conditions

Flail Chest

Condition Hierarchy (Ancestors)

Thoracic Injuries; Wounds and Injuries

Limitations and Caveats

Subject enrollment too low leading to insufficient data to analyze.

Results Point of Contact

• Title: Ajai K Malhotra, MD
• Organization: Virginia Commonwealth University

akmalhot@mcvh-vcu.edu

804-827-2409

Study Officials

• Ajai K Malhotra, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 22, 2010
• Study Start: September 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 6, 2015
• Results First Posted: August 6, 2015

Record last verified: 2015-08

Locations

US (7)