Flail Chest: A Randomized Controlled Study

NCT ID: NCT01308697

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-08-31

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.

Conditions

Flail Chest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Operative

Operative intervention

Group Type: ACTIVE_COMPARATOR

Operative fixation of flail chest

Intervention Type: PROCEDURE

Plate fixation

Non Operative Treatment

Non Operative management

Group Type: ACTIVE_COMPARATOR

Non Operative management

Intervention Type: OTHER

Non Operative treatment of Flail Chest

Interventions

Operative fixation of flail chest

Plate fixation

Intervention Type: PROCEDURE

Non Operative management

Non Operative treatment of Flail Chest

Intervention Type: OTHER

Other Intervention Names

Internal Fixation; Supportive care

Eligibility 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

• Attending physician does not believe the subject will survive their injuries

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter J O'Brien, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H10-03410

Identifier Type: -

Identifier Source: org_study_id