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Flail Chest: A Randomized Controlled Study

Sponsor
University of British Columbia (Other)
Overall Status
Completed
CT.gov ID
NCT01308697
Collaborator
(none)
14
Enrollment
2
Locations
2
Arms
28
Duration (Months)
7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Operative fixation of flail chest
  • Other: Non Operative management
 N/A

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.

Study Design

Study Type:
Interventional
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 :
Apr 1, 2011
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Operative

Operative intervention

Procedure: Operative fixation of flail chest
Plate fixation
Other Names:
  • Internal Fixation

    		•
    Active Comparator: Non Operative Treatment

    Non Operative management

    Other: Non Operative management
    Non Operative treatment of Flail Chest
    Other Names:
  • Supportive care

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary Outcome: Clinical outcomes [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Columbian Hospital New Westminster British Columbia Canada V3L 3W7
    2 Vancouver General Hospital Vancouver British Columbia Canada V5Z 4E3

    Sponsors and Collaborators

    • University of British Columbia

    Investigators

    • Principal Investigator: Peter J O'Brien, MD, University of British Columbia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT01308697
    Other Study ID Numbers:
    • H10-03410
    First Posted:
    Mar 4, 2011
    Last Update Posted:
    May 28, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by University of British Columbia
    Flail
    Chest
    Additional relevant MeSH terms:
    Flail Chest

    Study Results

    No Results Posted as of May 28, 2015