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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 81 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: 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.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sunnybrook Health Sciences Centre
Alberta Health services
The Ottawa Hospital
Hamilton Health Sciences Corporation
Vancouver General Hospital
Eastern Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Unstable chest wall injuries

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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