Flail Chest: A Randomized Controlled Study
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Purpose
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 | Intervention |
|---|---|
|
Flail Chest |
Procedure: Operative fixation of flail chest Other: Non Operative management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Operative Versus Non Operative Management of Flail Chest: A Randomized Controlled Feasibility Study |
- Primary Outcome: Clinical outcomes [ Time Frame: Day 1 Post Discharge ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Raman Johal | 604-875-5239 | raman.johal@vch.ca |
| Canada, British Columbia | |
| Royal Columbian Hospital | Recruiting |
| New Westminster, British Columbia, Canada, V3L 3W7 | |
| Principal Investigator: Naisan Garraway, MD; FRCSC | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E3 | |
| Contact: Raman Johal 604-875-5239 raman.johal@vch.ca | |
| Principal Investigator: Peter J O'Brien, MD | |
| Sub-Investigator: Morad Hameed, MD;MPH;FRCSC | |
| Sub-Investigator: Gerard P Slobogean, MD;MPH | |
| Principal Investigator: | Peter J O'Brien, MD | University of British Columbia |
More Information
No publications provided
| Responsible Party: | Dr Peter O'Brien, Head, Division of Orthopaedic Trauma, Department of Orthopaedics, University of British Columbia - Vancouver Coastal Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01308697 History of Changes |
| Other Study ID Numbers: | H10-03410 |
| Study First Received: | February 25, 2011 |
| Last Updated: | July 26, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Flail Chest |
Additional relevant MeSH terms:
|
Flail Chest Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013