Flail Chest: A Randomized Controlled Study

Flail Chest Clinical Trial

Official title:

Operative Versus Non Operative Management of Flail Chest: A Randomized Controlled Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308697
• Other study ID #: H10-03410
• Status: Completed
• Phase: N/A
• First received: February 25, 2011
• Last updated: May 27, 2015
• Start date: April 2011
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Flail Chest

Intervention

Procedure:
• Operative fixation of flail chest
Plate fixation

Other:
• Non Operative management
Non Operative treatment of Flail Chest

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1 Post Discharge	No