Flail Chest - Rib Fixation Study

Stopped early · Not applicable

Conditions studied: Flail Chest

In brief

The purpose of this study is to determine whether operative fixation of unilateral flail chest provides greater benefit than non-operative treatment.

Key facts

Study ID

NCT01147471

Run by

Virginia Commonwealth University

People needed

24

Starts

2010-09-01

Expected to finish

2014-08-01

Last updated by the study team

2015-08-06

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults >21 years and <75 years
• "Stove-in chest" to encompass both
• Unilateral flail chest (>3 ribs fractured at two places) or
• Contiguous rib fractures with at least 2 ribs pushed in > the rib diameter of the pushed in rib
• Mechanically ventilated

You may not qualify if…

• Patient unlikely to survive due to the trauma or age or multiple co-morbidities
• Stove-in chest patients that do not require early (less than or equal to 48 hours of injury) ventilatory support
• Bilateral flail chest
• Sternal flail
• P/F ratio < 200:1 over a period of greater than or equal to 6 hours while on the ventilator.
• Other injuries that will likely prolong tracheal intubation and mechanical ventilation eg significant head injury resulting in low GCS (Glasgow Coma Score, a scale used to assess the central nervous system in patients who have undergone trauma), spinal cord injury resulting in paralysis of some or all of the respiratory muscles etc. These are merely examples. It is in the opinion of the investigator/surgeon what injuries would prolong tracheal intubation.
• Any contra-indication to surgery including severe immunosuppression or severe chronic disease making elective surgery dangerous in the opinion of the surgeon
• Inability to proceed with any aspect of critical care due to personal beliefs, living will etc eg non acceptance of blood products
• Inability to obtain informed consent.
• Subject's refusal for follow up
• Pregnant women
• Prisoners
• Any other reason for which the potential subject is not a good candidate, in the opinion of the investigator.
• If the site investigator believes that a patient is a good candidate for the study (i.e. requires ventilation primarily due to altered chest wall mechanics) but fails to meet all criteria, site may contact Dr Ajai Malhotra to see if a waiver will be granted.

Where it is running

• Trauma Research & Education Foundation of Fresno — Fresno, California, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• The Board of Regents of the University of Oklahoma — Oklahoma City, Oklahoma, United States
• The University of Tennessee — Knoxville, Tennessee, United States
• Eastern Virginia Medical School — Norfolk, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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