Flail Chest: A Randomized Controlled 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.

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Key information

Conditions

Flail Chest Thoracic Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Columbian Hospital, New Westminster, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Operative fixation of flail chest

Procedure

Plate fixation

Other names: Internal Fixation

Non Operative management

Other

Non Operative treatment of Flail Chest

Other names: Supportive care

Primary outcomes

Primary Outcome: Clinical outcomes

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Mar 4, 2011
Registry last updated: May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed