Treatment of Acute, Unstable Chest Wall Injuries

NCT01367951 | Unknown

• 1 other identifier: Unstable chest wall injuries
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Blunt Injury of Thorax; Flail Chest; Chest Wall Injury Trauma; Rib Fracture

Keywords

unstable chest injury; flail chest; chest wall injury; rib fracture

Outcome Measures

Primary Outcomes (1)

• 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.

  28 Days

Secondary Outcomes (6)

• Number of days in the Intensive Care Unit (ICU)

  12 months

• Amount of pain medication administration, converted to oral morphine equivalence

  4 weeks

• Rate of Pneumonia

  12 months

• Pulmonary function assessment

  12 months

• Rate of return to work

  12 months

Study Arms (2)

Surgical fixation

EXPERIMENTAL

* 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

non-operative

NO INTERVENTION

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

Interventions

Surgical fixation PROCEDURE

* 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.

Surgical fixation

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>16 or skeletal maturity
• Meeting one of the two indication for surgical fixation of chest wall injury:
• Flail chest, defined as follows:
• unilateral segmental rib fractures; OR
• bilateral rib fractures; OR
• unilateral fractures combined with sternum fracture/dissociation Note: at least 3 of the rib fractures involved in the flail segment must demonstrate displacement.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• Hamilton Health Sciences Corporation: collaborator
• Vancouver General Hospital: collaborator
• Eastern Health: collaborator
• The Ottawa Hospital: collaborator
• Alberta Health services: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

• 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.

  PMID: 36129720 DERIVED

MeSH Terms

Conditions

Flail Chest; Rib Fractures

Interventions

Surgical Fixation Devices

Condition Hierarchy (Ancestors)

Thoracic Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Michael D McKee, MD, FRCS(C)

  St. Michael's Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 7, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

CA (1)