Treatment of Acute, Unstable Chest Wall Injuries

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by St. Michael's Hospital, Toronto
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Hamilton Health Sciences Corporation
Vancouver General Hospital
Eastern Health
The Ottawa Hospital
AHS Cancer Control Alberta
Information provided by (Responsible Party):
Michael McKee, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01367951
First received: May 27, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Blunt Injury of Thorax
Flail Chest
Chest Wall Injury Trauma
Rib Fracture
Procedure: Surgical fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi Centered Randomized Controlled Trial of Operative Versus Non-operative Treatment of Acute, Unstable Chest Wall Injuries

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Ventilator-free days (VFD) [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of days in the Intensive Care Unit (ICU) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The total daily pain medication administration will be calculated, and converted to daily oral (PO) morphine equivalence.

  • Rate of Pneumonia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The number of times patient is diagnosed with pneumonia over 12 months post injury

  • Pulmonary function assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Using SF-36 questionnaire we will assess the patient's well-being and functional health


Estimated Enrollment: 206
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical fixation
  • 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.
Procedure: Surgical fixation
  • 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.
No Intervention: non-operative
  1. Mechanical ventilation: Patients in respiratory distress will receive endotracheal intubation, and placed on mechanical ventilation. PEEP will be utilized as needed, at the discretion of the ICU and respiratory therapy team.
  2. Other conservative means/Pulmonary toilet:Patients will receive aggressive pulmonary toilet (suctioning of ET tube as needed), chest physiotherapy (as per standard local protocol), and will have the head of the bed elevated to 30° unless contraindicated (ie unstable C-spine injury).
  3. Pain control:Epidural catheters, intercostal nerve block, PCA, IV/PO pain medication

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >16 or skeletal maturity
  • Meeting one of the two indication for surgical fixation of chest wall injury:

    1. Flail chest, defined as follows:

      • 3 unilateral segmental rib fractures; OR
      • 3 bilateral rib fractures; OR
      • 3 unilateral fractures combined with sternum fracture/dissociation
    2. Severe deformity of the chest wall (Diagnosed by CT scan). Defined as follows:

      • Severe displacement of 3 or more ribs (by minimum 15mm each); OR
      • Marked loss thoracic volume/caved in chest (>25% volume loss in involved lobe(s)); OR
      • Overriding of 3 or more rib fractures (by minimum 15mm each); OR
      • Two or more rib fractures associated with intra-parenchymal injury - ie ribs in the lung, in the parenchyma

Exclusion Criteria:

  • Anatomic location of rib fractures are not amenable to surgical fixation (eg fractures directly adjacent to spinal column)
  • Rib fractures primarily involving floating ribs (ribs 10-12)
  • Home Oxygen (O2) requirement
  • Other significant injuries that may require long term intubation:
  • Severe pulmonary contusion (Defined as PaO2/FIO2 ratio <200 with radiological evidence of pulmonary infiltrates WITHIN 24 hours of THORACIC TRAUMA)
  • Severe head injury/Traumatic brain injury - (GCS ≤ 8 at 48 hrs post injury. If unable to assess full GCS due to intubation or other causes, GCS motor ≤4 at 48 hrs post injury)
  • Upper airway injury requiring long term intubation and mechanical ventilation (e.g. tracheal disruption)
  • Acute quadriplegia/quadraparesis
  • Head and neck burn injuries, or inhalation burn injuries
  • Dementia or other inability to complete follow-up questionnaires
  • Medically unstable for OR (e.g. haemodynamic instability, acidosis, coagulopathy, etc.)* or unlikely to survive 1 year follow-up, in the opinion of the attending physician
  • Lack of informed consent from patient or substitute decision maker
  • Randomization > 72 hours from injury
  • ORIF > 96 hours from injury (if randomized to surgical fixation group)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367951

Contacts
Contact: Michael McKee, MD, FRCS(C) 416-864-5880 mckeem@smh.ca
Contact: Emil Schemitsch, MD, FRCS(C) 416-864-6003 schemitsche@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Michael McKee, MD, FRCSC    416-864-5880    mckeem@smh.ca   
Contact: Milena Vicente, RN, CCRP    416-864-6060 ext 2608    vicentem@smh.ca   
Principal Investigator: Michael D McKee, Md, FRCS(C)         
Principal Investigator: Emil Schemitsch, MD, FRCS(C)         
Sub-Investigator: Aaron Nauth, MD, FRCS(C)         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Sunnybrook Health Sciences Centre
Hamilton Health Sciences Corporation
Vancouver General Hospital
Eastern Health
The Ottawa Hospital
AHS Cancer Control Alberta
Investigators
Principal Investigator: Michael D McKee, MD, FRCS(C) St. Michael's Hospital, University of Toronto
  More Information

No publications provided

Responsible Party: Michael McKee, MD, FRCS(C), St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01367951     History of Changes
Other Study ID Numbers: Unstable chest wall injuries
Study First Received: May 27, 2011
Last Updated: March 19, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
unstable chest injury
flail chest
chest wall injury
rib fracture

Additional relevant MeSH terms:
Flail Chest
Fractures, Bone
Rib Fractures
Thoracic Injuries
Wounds, Nonpenetrating
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014