Clinical Trial: Treatment of Acute, Unstable Chest Wall Injuries

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multi Centered Randomized Controlled Trial of Operative Versus Non-operative Treatment of Acute, Unstable Chest Wall Injuries

Brief Summary: 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.

Detailed Summary:
Sponsor: St. Michael's Hospital, Toronto

Current Primary Outcome: Ventilator-free days (VFD) [ Time Frame: 28 Days ]

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.


Original Primary Outcome: Number of days on mechanical ventilation [ Time Frame: 12 months ]

Total number of days on mechanical ventilator over 12 months post injury. If patient does not require intubation, the total days will be "0"


Current Secondary Outcome:

  • Number of days in the Intensive Care Unit (ICU) [ Time Frame: 12 months ]
    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.
  • Amount of pain medication administration, converted to oral morphine equivalence [ Time Frame: 4 weeks ]
    The total daily pain medication administration will be calculated, and converted to daily oral (PO) morphine equivalence.
  • Rate of Pneumonia [ Time Frame: 12 months ]
    The number of times patient is diagnosed with pneumonia over 12 months post injury
  • Pulmonary function assessment [ Time Frame: 12 months ]
    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
  • Rate of return to work [ Time Frame: 12 months ]
    to assess if patient has returned to work at 12 months, and at what capacity
  • assessment of functional health and well being [ Time Frame: 12 months ]
    Using SF-36 questionnaire we will assess the patient's well-being and functional health


Original Secondary Outcome:

  • Number of days in ICU [ Time Frame: 12 months ]
    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.
  • Amount of pain medication administration, converted to oral morphine equivalence [ Time Frame: 4 weeks ]
    The total daily pain medication administration will be calculated, and converted to daily PO morphine equivalence.
  • Rate of Pneumonia [ Time Frame: 12 months ]
    The number of times patient is diagnosed with pneumonia over 12 months post injury
  • Pulmonary function assessment [ Time Frame: 12 months ]
    spirometry measurement of total lung capacity (TLC), forced vital capacity (FVC) and forced expiratory volume at 1 second (FEV1) at 12 months post injury
  • Rate of return to work [ Time Frame: 12 months ]
    to assess if patient has returned to work at 12 months, and at what capacity
  • assessment of functional health and well being [ Time Frame: 12 months ]
    Using SF-36 questionnaire we will assess the patient's well-being and functional health


Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: May 27, 2011
Date Started: July 2011
Date Completion: December 2017
Last Updated: October 24, 2016
Last Verified: October 2016