- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01367951
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
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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-
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:
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
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
|
|
No Intervention: non-operative
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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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Flail Chest
-
University of British ColumbiaCompleted
-
Legacy Biomechanics LaboratorySynthes Inc.CompletedFlail ChestUnited States
-
Sahlgrenska University Hospital, SwedenCompletedRib; Fracture, Multiple, With Flail ChestSweden
-
Virginia Commonwealth UniversitySynthes Inc.Terminated
-
The AlfredCompletedVentilation | Flail ChestAustralia
-
Poitiers University HospitalUnknownPolytraumatises With Rib FracturesFrance
-
Darwin AngRecruitingFlail Chest | Rib FractureUnited States
-
Sunnybrook Health Sciences CentreRecruitingPain | Trauma | Pain, Acute | Trauma Injury | Pain, Chronic | Rib Fractures | Rib Fracture Multiple | Rib; Fracture, With Flail ChestCanada
Clinical Trials on Surgical fixation
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Medical University of ViennaRecruiting
-
Brno University HospitalMasaryk UniversityRecruitingCatheter ComplicationsCzechia
-
University of CalgaryUnity Health Toronto; Queen Elizabeth II Health Sciences Centre; Montreal General... and other collaboratorsRecruiting
-
Sohag UniversityNot yet recruitingMultiple Fractures of Ribs
-
University of Missouri-ColumbiaTerminatedMetacarpal FractureUnited States
-
Cairo UniversityActive, not recruitingVertical Deficeny of Posterior MandibleEgypt
-
Sahlgrenska University Hospital, SwedenCompletedRib; Fracture, Multiple, With Flail ChestSweden
-
Unity Health TorontoRecruitingKnee Fracture | Distal Femur Fracture | Periprosthetic Fracture Around Prosthetic Joint Implant KneeCanada
-
Menoufia UniversityCompletedDegenerative Spondylolisthesis G1Egypt
-
Unity Health TorontoNYU Langone Health; Rush University Medical Center; Brigham and Women's Hospital and other collaboratorsRecruiting