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Treatment of Acute, Unstable Chest Wall Injuries

Primary Purpose

Blunt Injury of Thorax, Flail Chest, Chest Wall Injury Trauma

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Surgical fixation
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blunt Injury of Thorax focused on measuring unstable chest injury, flail chest, chest wall injury, rib fracture

Eligibility Criteria

16 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgical fixation

non-operative

Arm Description

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.

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. 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). Pain control:Epidural catheters, intercostal nerve block, PCA, IV/PO pain medication

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 27, 2011
Last Updated
June 16, 2021
Sponsor
Unity Health Toronto
Collaborators
Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation, Vancouver General Hospital, Eastern Health, The Ottawa Hospital, Alberta Health services
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1. Study Identification

Unique Protocol Identification Number
NCT01367951
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation, Vancouver General Hospital, Eastern Health, The Ottawa Hospital, Alberta Health services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blunt Injury of Thorax, Flail Chest, Chest Wall Injury Trauma, Rib Fracture
Keywords
unstable chest injury, flail chest, chest wall injury, rib fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical fixation
Arm Type
Experimental
Arm Description
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.
Arm Title
non-operative
Arm Type
No Intervention
Arm Description
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. 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). Pain control:Epidural catheters, intercostal nerve block, PCA, IV/PO pain medication
Intervention Type
Procedure
Intervention Name(s)
Surgical fixation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ventilator-free days (VFD)
Description
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.
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Number of days in the Intensive Care Unit (ICU)
Description
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.
Time Frame
12 months
Title
Amount of pain medication administration, converted to oral morphine equivalence
Description
The total daily pain medication administration will be calculated, and converted to daily oral (PO) morphine equivalence.
Time Frame
4 weeks
Title
Rate of Pneumonia
Description
The number of times patient is diagnosed with pneumonia over 12 months post injury
Time Frame
12 months
Title
Pulmonary function assessment
Description
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
Time Frame
12 months
Title
Rate of return to work
Description
to assess if patient has returned to work at 12 months, and at what capacity
Time Frame
12 months
Title
assessment of functional health and well being
Description
Using SF-36 questionnaire we will assess the patient's well-being and functional health
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >16 or skeletal maturity Meeting one of the two indication 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D McKee, MD, FRCS(C)
Organizational Affiliation
St. Michael's Hospital, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
36129720
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.
Results Reference
derived

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Treatment of Acute, Unstable Chest Wall Injuries

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