Flail Chest: A Randomized Controlled Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01308697
First received: February 25, 2011
Last updated: February 3, 2014
Last verified: February 2014

February 25, 2011
February 3, 2014
April 2011
August 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01308697 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Flail Chest: A Randomized Controlled Study
Operative Versus Non Operative Management of Flail Chest: A Randomized Controlled Feasibility Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Flail Chest
  • Procedure: Operative fixation of flail chest
    Plate fixation
    Other Name: Internal Fixation
  • Other: Non Operative management
    Non Operative treatment of Flail Chest
    Other Name: Supportive care
  • Active Comparator: Operative
    Operative intervention
    Intervention: Procedure: Operative fixation of flail chest
  • Active Comparator: Non Operative Treatment
    Non Operative management
    Intervention: Other: Non Operative management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01308697
H10-03410
No
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Peter J O'Brien, MD University of British Columbia
University of British Columbia
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP