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
  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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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


Enrollment: 14
Study Start Date: April 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308697

Locations
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01308697     History of Changes
Other Study ID Numbers: H10-03410
Study First Received: February 25, 2011
Last Updated: February 3, 2014
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 August 21, 2014