Flail Chest: A Randomized Controlled Study
Primary Purpose
Flail Chest
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Operative fixation of flail chest
Non Operative management
Sponsored by
About this trial
This is an interventional treatment trial for Flail Chest focused on measuring Flail, Chest
Eligibility Criteria
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
Sites / Locations
- Royal Columbian Hospital
- Vancouver General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Operative
Non Operative Treatment
Arm Description
Operative intervention
Non Operative management
Outcomes
Primary Outcome Measures
Primary Outcome: Clinical outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01308697
First Posted
February 25, 2011
Last Updated
May 27, 2015
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01308697
Brief Title
Flail Chest: A Randomized Controlled Study
Official Title
Operative Versus Non Operative Management of Flail Chest: A Randomized Controlled Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flail Chest
Keywords
Flail, Chest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Operative
Arm Type
Active Comparator
Arm Description
Operative intervention
Arm Title
Non Operative Treatment
Arm Type
Active Comparator
Arm Description
Non Operative management
Intervention Type
Procedure
Intervention Name(s)
Operative fixation of flail chest
Other Intervention Name(s)
Internal Fixation
Intervention Description
Plate fixation
Intervention Type
Other
Intervention Name(s)
Non Operative management
Other Intervention Name(s)
Supportive care
Intervention Description
Non Operative treatment of Flail Chest
Primary Outcome Measure Information:
Title
Primary Outcome: Clinical outcomes
Description
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
Time Frame
Day 1 Post Discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J O'Brien, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Flail Chest: A Randomized Controlled Study
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