Unstable chest injuries are common in poly trauma patients. They can lead to severe pulmonary restriction, loss of lung volume, difficulty with ventilation and can render the patient to require intubation and mechanical ventilation. Traditionally these injuries have been treated non-operatively, however in the past decade there has been numerous studies suggesting improved outcomes with surgical fixation. Surgical fixation can significantly decrease time spent in ICU as well as day on mechanical ventilation. The investigators aim is to conduct a randomized control trial of these injuries, to compare non-operative treatment with surgical fixation. The investigators' hypothesis is that surgically treated patient will have significantly improved outcomes compared to those treated non-operatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
207
* The fractures will be reduced and stabilized by use of plates and screws * Attempt will be made to stabilize ribs 3-7, as these are surgically accessible and most important in maintaining integrity of the chest cavity. * Goal is not to fix all the fractures, but to fix sufficient fractures to create an internal splint and allow chest wall motion to occur as a unit. In case of fibs fractured at numerous locations, as many fragments will be reduced and stabilized as necessary to ensure movement as a unit. * Chest tube(s) will be placed at the discretion of the treating surgeon in patients with pre-operative or intra-operative violation of the pleural cavity (ie pre-op pneumothorax/haemothorax, iatrogenic pleural injury). No post-operative drains will be inserted.
St. Michael's Hospital
Toronto, Ontario, Canada
Ventilator-free days (VFD)
To compare early surgical fixation versus conventional, non-surgical treatment of unstable chest injuries on the basis of our primary outcome measure of days spent free from a mechanical ventilator in the first 28 days following injury.
Time frame: 28 Days
Number of days in the Intensive Care Unit (ICU)
The total number of days in ICU will be calculated over the 12 months period post injury. If no ICU stay is needed the total days in ICU will be 0.
Time frame: 12 months
Amount of pain medication administration, converted to oral morphine equivalence
The total daily pain medication administration will be calculated, and converted to daily oral (PO) morphine equivalence.
Time frame: 4 weeks
Rate of Pneumonia
The number of times patient is diagnosed with pneumonia over 12 months post injury
Time frame: 12 months
Pulmonary function assessment
spirometry measurement of total lung capacity (TLC), forced vital capacity (FVC) and forced expiratory volume at 1 second (FEV1), measured at 3 months and at 12 months post injury
Time frame: 12 months
Rate of return to work
to assess if patient has returned to work at 12 months, and at what capacity
Time frame: 12 months
assessment of functional health and well being
Using SF-36 questionnaire we will assess the patient's well-being and functional health
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.