Blunt Injury of ThoraxNCT01367951
Treatment of Acute, Unstable Chest Wall Injuries
A study testing Surgical fixation in people with Blunt Injury of Thorax and Flail Chest, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Blunt Injury of Thorax, Flail Chest, Chest Wall Injury Trauma
- What is being tested?
- Surgical fixation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Surgical fixation
- Keywords
- unstable chest injury, flail chest, chest wall injury, rib fracture
- Medical subject headings
- Flail Chest, Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical fixationProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 Days
Secondary outcomes (6)
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.
Measured: 12 months
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.
Measured: 4 weeks
Rate of Pneumonia
The number of times patient is diagnosed with pneumonia over 12 months post injury
Measured: 12 months
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
Measured: 12 months
Rate of return to work
to assess if patient has returned to work at 12 months, and at what capacity
Measured: 12 months
assessment of functional health and well being
Using SF-36 questionnaire we will assess the patient's well-being and functional health
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2018
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blunt Injury of ThoraxStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation, Vancouver General Hospital, Eastern Health, The Ottawa Hospital, Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Michael D McKee, MD, FRCS(C), Principal investigator, St. Michael's Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367951
- Sponsor's protocol ID
- Unstable chest wall injuries
- Status last verified
- Jun 2021
- First submitted
- 27 May 2011
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36129720
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Centered Randomized Controlled Trial of Operative Versus Non-operative Treatment of Acute, Unstable Chest Wall Injuries
- ClinicalTrials.gov ID
- NCT01367951
- Acronym / sponsor ID
- Unstable chest wall injuries
- Keywords
- unstable chest injury, flail chest, chest wall injury, rib fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Hamilton Health Sciences Corporation, Vancouver General Hospital, Eastern Health, The Ottawa Hospital, Alberta Health services
- Study start
- Jul 2011
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical fixation | Experimental | 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. |
| 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 |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age >16 or skeletal maturity
- Meeting one of the two indication for surgical fixation of chest wall injury:
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Surgical fixation |
Primary outcome
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.
6 secondary outcomes
Number of days in the Intensive Care Unit (ICU)
Time frame: 12 months
Amount of pain medication administration, converted to oral morphine equivalence
Time frame: 4 weeks
Rate of Pneumonia
Time frame: 12 months
Pulmonary function assessment
Time frame: 12 months
Rate of return to work
Time frame: 12 months
assessment of functional health and well being
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Derived from this study: PubMed 36129720Dehghan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D McKee, MD, FRCS(C) principal investigator
St. Michael's Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical fixation in people with Blunt Injury of Thorax and Flail Chest, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days (VFD) (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01367951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.