Flail Chest: A Randomized Controlled Study

Not Applicable

Completed

• Conditions: Flail Chest
• Interventions: Other: Non Operative management; Procedure: Operative fixation of flail chest

• Registration Number: NCT01308697
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Study Start: 2011-04
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non Operative Treatment	Non Operative management	Non Operative management
Operative	Operative fixation of flail chest	Operative intervention

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada