NCT01367951.

Trial name or title	A Multi Centre Randomized Controlled Trial of Operative Versus Non‐operative Treatment of Acute, Unstable Chest Wall Injuries
Methods	Study design: RCT Multicenter Setting: St. Michael's Hospital, Toronto, ON, Canada Period: 2011‐2015 Sample size: 206 participants Follow‐up: 12 months
Participants	Inclusion criteria: Aged >16 years or skeletal maturity Meeting 1 of the 2 indications for surgical fixation of chest wall injury: Flail chest, defined as follows: 3 unilateral segmental rib fractures; OR 3 bilateral rib fractures; OR 3 unilateral fractures combined with sternum fracture/dissociation Severe deformity of the chest wall (diagnosed by computed tomography scan), defined as follows: severe displacement of ≥ 3 ribs (by minimum 15 mm each); OR marked loss thoracic volume/caved in chest (> 25% volume loss in involved lobe(s)); OR overriding of ≥ 3 rib fractures (by minimum 15 mm each); OR ≥ 2 rib fractures associated with intraparenchymal injury ‐ i.e. ribs in the lung, in the parenchyma Exclusion criteria: anatomic location of rib fractures not amenable to surgical fixation (e.g. fractures directly adjacent to spinal column) rib fractures primarily involving floating ribs (ribs 10‐12) home oxygen requirement other significant injuries that may require long‐term intubation severe pulmonary contusion (defined as PaO2/FIO2 ratio < 200 with radiologic evidence of pulmonary infiltrates within 24 hours of thoracic trauma) severe head injury/traumatic brain injury (GCS ≤ 8 at 48 hours postinjury. If unable to assess full GCS due to intubation or other causes, GCS motor ≤ 4 at 48 hours postinjury) 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. hemodynamic instability, acidosis, coagulopathy, etc.) or unlikely to survive 1‐year follow‐up, in the opinion of the attending physician lack of informed consent from person or substitute decision maker randomization > 72 hours from injury ORIF > 96 hours from injury (if randomized to surgical fixation group)
Interventions	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 ribs 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 people with preoperative or intraoperative violation of the pleural cavity (i.e. preoperative pneumothorax/hemothorax, iatrogenic pleural injury). No postoperative drains will be inserted Nonsurgical Mechanical ventilation: people 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 Other conservative means/pulmonary toilet: participants will receive aggressive pulmonary toilet (suctioning of endotracheal tube as needed), chest physical therapy (as per standard local protocol), and will have the head of the bed elevated to 30° unless contraindicated (i.e. unstable C‐spine injury) Pain control: epidural catheters, intercostal nerve block, participant‐controlled analgesia, intravenous/oral pain medication
Outcomes	Primary outcome: Ventilator‐free days (28 days) To compare early surgical fixation vs. conventional, nonsurgical 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 outcomes: Number of days in ICU (12 months) The total number of days in ICU will be calculated over the 12‐month period postinjury. If no ICU stay is needed the total days in ICU will be 0 Amount of pain medication administration, converted to oral morphine equivalence (4 weeks) The total daily pain medication administration will be calculated, and converted to daily oral morphine equivalence Rate of pneumonia (12 months) The number of times participant is diagnosed with pneumonia over 12 months postinjury Pulmonary function assessment (12 months) Spirometry measurement of total lung capacity, forced vital capacity, and forced expiratory volume in 1 second measured at 3 and 12 months postinjury Rate of return to work (12 months) To assess if participant has returned to work at 12 months, and at what capacity Assessment of functional health and wellbeing (12 months) Using 36‐item Short Form questionnaire to assess the participant's wellbeing and functional health
Starting date	July 2011
Contact information	Michael McKee, MD, FRCS(C), 416‐864‐5880, mckeem@smh.ca Emil Schemitsch, MD, FRCS(C), 416‐864‐6003, schemitsche@smh.ca
Notes

GCS: Glasgow Coma Score; ICU: intensive care unit; ORIF: open reduction and internal fixation; PaO₂/FIO₂ ratio: arterial oxygen partial pressure to fractional inspired oxygen ratio; PEEP: positive end‐expiratory pressure; RCT: randomized controlled trial.