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Flail Chest: A Randomized Controlled Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01308697
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:

Flail chest refers to a section of the rib cage that has broken away from the surrounding ribs. Usually, more than one rib is involved, and they are broken in at least two places. Flail chest typically is the result of blunt chest trauma. As a result of flail chest, the chest wall becomes unstable and dangers of life threatening respiratory failure and hypoxemia (lack of oxygen to circulating blood which will lead to organ damage or failure)occur.

Currently, these injuries are treated non operatively. However, small case series have demonstrated that operative management can improve Intensive Care Unit (ICU) length of stay, improved pulmonary function and decreased pain leading to decreased duration of mechanical ventilation, and the incidence of complications related to this injury.

This study hopes to provide information on whether a prospective randomized trial is feasible by first undertaking a small pilot study to determine rate of recruitment, data collection methods, and integrity of study protocol.

Null Hypothesis 1: Enrollment of subjects with flail chest rib fractures into a prospective multi-centre RCT is not feasible and a larger clinical trial is unlikely to be completed.

Condition or disease Intervention/treatment Phase
Flail Chest Procedure: Operative fixation of flail chest Other: Non Operative management Not Applicable

Detailed Description:
The optimum treatment of flail chest rib fractures is currently unknown. The standard of care for these injuries at most centers in North America, includes a progressive algorithm of epidural anesthesia, mechanical ventilation, and tracheostomy. Surgical management of flail chest injuries has previously been reserved for refractory cases unable to wean from mechanical ventilation or severe chest wall instability. However, the use of surgical stabilization of multiple rib fractures has demonstrated substantial improvements in ICU length of stay, duration of mechanical ventilation, and the incidences of pneumonia, tracheotomy, and reintubation. These results have been reported in small cases series without prospective or randomized trial designs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Operative Versus Non Operative Management of Flail Chest: A Randomized Controlled Feasibility Study
Study Start Date : April 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Active Comparator: Operative
Operative intervention
Procedure: Operative fixation of flail chest
Plate fixation
Other Name: Internal Fixation

Active Comparator: Non Operative Treatment
Non Operative management
Other: Non Operative management
Non Operative treatment of Flail Chest
Other Name: Supportive care

Primary Outcome Measures :
  1. Primary Outcome: Clinical outcomes [ Time Frame: Day 1 Post Discharge ]
    Pilot study intends to review numerous clinical outcomes or variable of interest to assist in selecting a primary outcome and sample size for the future definitive trial. Currently Length of Stay in a high acuity unit is the planned primary outcome measure for the definitive trial

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age greater than or equal to 18 years old
  • greater than or equal to 4 adjacent rib fractures, with greater than one fracture per rib
  • provide informed consent

Exclusion Criteria:

  • Does not meet inclusion criteria
  • Attending physician does not believe the subject will survive their injuries

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01308697

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Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 4E3
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Peter J O'Brien, MD University of British Columbia
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Responsible Party: University of British Columbia Identifier: NCT01308697    
Other Study ID Numbers: H10-03410
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by University of British Columbia:
Additional relevant MeSH terms:
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Flail Chest
Thoracic Injuries
Wounds and Injuries