Treatment of Acute, Unstable Chest Wall Injuries

This study is currently recruiting participants.

Verified February 2013 by St. Michael's Hospital, Toronto

Sponsor:

Collaborators:

Sunnybrook Health Sciences Centre

Hamilton Health Sciences Corporation

Vancouver General Hospital

Eastern Health

The Ottawa Hospital

Alberta Health Services

Information provided by (Responsible Party):

Michael McKee, St. Michael's Hospital, Toronto

ClinicalTrials.gov Identifier:

NCT01367951

First received: May 27, 2011

Last updated: February 28, 2013

Last verified: February 2013

History of Changes

Purpose

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.

Condition	Intervention
Blunt Injury of Thorax Flail Chest Chest Wall Injury Trauma Rib Fracture	Procedure: Surgical fixation

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multi Centered Randomized Controlled Trial of Operative Versus Non-operative Treatment of Acute, Unstable Chest Wall Injuries

Resource links provided by NLM:

MedlinePlus related topics: Chest Injuries and Disorders Fractures Injuries Wounds

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

Number of days on mechanical ventilation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Total number of days on mechanical ventilator over 12 months post injury. If patient does not require intubation, the total days will be "0"

Secondary Outcome Measures:

Number of days in the Intensive Care Unit (ICU) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The total daily pain medication administration will be calculated, and converted to daily oral (PO) morphine equivalence.
Rate of Pneumonia [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The number of times patient is diagnosed with pneumonia over 12 months post injury
Pulmonary function assessment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
spirometry measurement of total lung capacity (TLC), forced vital capacity (FVC) and forced expiratory volume at 1 second (FEV1) at 12 months post injury
Rate of return to work [ Time Frame: 12 months ] [ Designated as safety issue: No ]
to assess if patient has returned to work at 12 months, and at what capacity
assessment of functional health and well being [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Using SF-36 questionnaire we will assess the patient's well-being and functional health

Estimated Enrollment:	80
Study Start Date:	July 2011
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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

Arms

Assigned Interventions

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

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

Eligibility

Ages Eligible for Study:	16 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
2. Severe deformity of the chest wall (Diagnosed by CT scan). Defined as follows:
  - Severe displacement of 3 or more ribs (by minimum 15mm each); 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367951

Contacts

Contact: Michael McKee, MD, FRCS(C)	416-864-5880	mckeem@smh.ca
Contact: Emil Schemitsch, MD, FRCS(C)	416-864-6003	schemitsche@smh.ca

Locations

Canada, Ontario
St. Michael's Hospital	Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Michael McKee, MD, FRCSC 416-864-5880 mckeem@smh.ca
Contact: Milena Vicente, RN, CCRP 416-864-6060 ext 2608 vicentem@smh.ca
Principal Investigator: Michael D McKee, Md, FRCS(C)
Principal Investigator: Emil Schemitsch, MD, FRCS(C)
Sub-Investigator: Aaron Nauth, MD, FRCS(C)

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Sunnybrook Health Sciences Centre

Hamilton Health Sciences Corporation

Vancouver General Hospital

Eastern Health

The Ottawa Hospital

Alberta Health Services

Investigators

Principal Investigator:

Michael D McKee, MD, FRCS(C)

St. Michael's Hospital, University of Toronto

More Information

No publications provided

Responsible Party:	Michael McKee, MD, FRCS(C), St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT01367951 History of Changes
Other Study ID Numbers:	Unstable chest wall injuries
Study First Received:	May 27, 2011
Last Updated:	February 28, 2013
Health Authority:	Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:

unstable chest injury
flail chest
chest wall injury
rib fracture

Additional relevant MeSH terms:

Flail Chest
Fractures, Bone
Rib Fractures

Wounds, Nonpenetrating
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013

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