Clinical trial NCT01367951: Treatment of Acute, Unstable Chest Wall Injuries
Official title: A Multi Centered Randomized Controlled Trial of Operative Versus Non-operative Treatment of Acute, Unstable Chest Wall Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blunt Injury of Thorax
Flail Chest
Chest Wall Injury Trauma
Rib Fracture
Keywords: unstable chest injury
flail chest
chest wall injury
rib fracture
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Hamilton Health Sciences Corporation
name: Vancouver General Hospital
name: Eastern Health
name: The Ottawa Hospital
name: Alberta Health services
First posted: 2011-06-07
Enrollment: 207
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 Note: at least 3 of the rib fractures involved in the flail segment must demonstrate displacement.
  2. Severe deformity of the chest wall (Diagnosed by CT scan). Defined as follows:

     * Severe (100%) displacement of 3 or more ribs 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)
* Age \> 85

Primary outcomes:
measure: Ventilator-free days (VFD)
timeFrame: 28 Days
Secondary outcomes:
measure: Number of days in the Intensive Care Unit (ICU)
timeFrame: 12 months
measure: Amount of pain medication administration, converted to oral morphine equivalence
timeFrame: 4 weeks
measure: Rate of Pneumonia
timeFrame: 12 months
measure: Pulmonary function assessment
timeFrame: 12 months
measure: Rate of return to work
timeFrame: 12 months
measure: assessment of functional health and well being
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital, University of Toronto
name: Michael D McKee, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dehghan N, Nauth A, Schemitsch E, Vicente M, Jenkinson R, Kreder H, McKee M; Canadian Orthopaedic Trauma Society and the Unstable Chest Wall RCT Study Investigators. Operative vs Nonoperative Treatment of Acute Unstable Chest Wall Injuries: A Randomized Clinical Trial. JAMA Surg. 2022 Nov 1;157(11):983-990. doi: 10.1001/jamasurg.2022.4299.