Flail Chest: A Randomized Controlled Study

NCT01308697 | Completed

• 1 other identifier: H10-03410
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Flail Chest

Keywords

Flail; Chest

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Operative

ACTIVE COMPARATOR

Operative intervention

Procedure: Operative fixation of flail chest

Non Operative Treatment

ACTIVE COMPARATOR

Non Operative management

Other: Non Operative management

Interventions

Operative fixation of flail chest PROCEDURE

Plate fixation

Also known as: Internal Fixation

Operative

Non Operative management OTHER

Non Operative treatment of Flail Chest

Also known as: Supportive care

Non Operative Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 4E3, Canada

Location

MeSH Terms

Conditions

Flail Chest

Interventions

Fracture Fixation, Internal; Palliative Care

Condition Hierarchy (Ancestors)

Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Peter J O'Brien, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 4, 2011
• Study Start: April 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

CA (2)