Clinical Trial: Flail Chest - Rib Fixation Study

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Flail Chest: Early Operative Fixation Versus Non-operative Management - a Prospective Randomized Study

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 Summary:

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 wit
Sponsor: Virginia Commonwealth University

Current Primary Outcome:

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

Original Primary Outcome:

• Morbidity [ Time Frame: Measured daily during hospitalization and at 3 and 6 months post-discharge ]

  Pain as measured on analog pain scale, infections, days on ventilator, days in ICU, days in hospital, and operative complications during hospital stay.

  At 3 and 6 months post-discharge analog pain measurement, infections and operative complications.

• Mortality [ Time Frame: Measured any time during hopsital stay ]

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Virginia Commonwealth University

Dates:
Date Received: June 7, 2010
Date Started: September 2010
Date Completion:
Last Updated: August 4, 2015
Last Verified: August 2015