Treatment of Acute, Unstable Chest Wall Injuries

June 16, 2021 updated by: Unity Health Toronto

A Multi Centered Randomized Controlled Trial of Operative Versus Non-operative Treatment of Acute, Unstable Chest Wall Injuries

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 83 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator-free days (VFD)
Time Frame: 28 Days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days in the Intensive Care Unit (ICU)
Time Frame: 12 months
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.
12 months
Amount of pain medication administration, converted to oral morphine equivalence
Time Frame: 4 weeks
The total daily pain medication administration will be calculated, and converted to daily oral (PO) morphine equivalence.
4 weeks
Rate of Pneumonia
Time Frame: 12 months
The number of times patient is diagnosed with pneumonia over 12 months post injury
12 months
Pulmonary function assessment
Time Frame: 12 months
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
12 months
Rate of return to work
Time Frame: 12 months
to assess if patient has returned to work at 12 months, and at what capacity
12 months
assessment of functional health and well being
Time Frame: 12 months
Using SF-36 questionnaire we will assess the patient's well-being and functional health
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael D McKee, MD, FRCS(C), St. Michael's Hospital, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2018

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

June 4, 2011

First Posted (Estimate)

June 7, 2011

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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