Flail Chest: A Randomized Controlled Study
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|ClinicalTrials.gov Identifier: NCT01308697|
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : May 28, 2015
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Operative
Procedure: Operative fixation of flail chest
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: 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
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 ClinicalTrials.gov identifier (NCT number): NCT01308697
|Canada, British Columbia|
|Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 3W7|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 4E3|
|Principal Investigator:||Peter J O'Brien, MD||University of British Columbia|