Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00298259|
Recruitment Status : Completed
First Posted : March 2, 2006
Last Update Posted : December 11, 2012
Background: Fracture of several ribs in more than one place as the result of trauma, leads to paradoxical movement of the chest wall and ventilatory failure. The mainstay of management in these patients has traditionally been analgesia and positive pressure ventilation to splint the chest wall and allow healing of the ribs to begin. However, this management option leads to prolonged intensive care unit (ICU) stay with increasing complication rates as patients remain on a ventilator for prolonged periods. Patients often remain on a ventilator for two to three weeks while waiting for enough rib healing to provide sufficient chest wall stability to allow the patient to take over all their breathing themselves. Until that time, patients are at risk of pneumonia and sepsis and other complications. Long term disabilities which have been reported in these patients include ongoing pain syndromes, inability to return to work, particularly manual type labour and cosmetic chest wall deformities.
An alternative treatment strategy is to operatively fix the ribs. By fixing the ribs operatively, the patient no longer requires internal pneumatic stabilization (provided by mechanical ventilation) and can be weaned from the ventilator within days rather than weeks. This can potentially lead to earlier discharge from the intensive care unit, and an avoidance of the multiple complications which arise in the ventilated patient. Rib fixation may also lead to less pain and deformity, improved mobility in the post injury phase and earlier return to work.
Hypothesis: that early operative fixation of ribs in patients presenting with flail chest secondary to trauma will result in less mechanical ventilatory requirements, earlier discharge from the intensive care unit and lower rate of complications associated with prolonged mechanical ventilation. This will lead to cost savings in the treatment of these patients.
|Condition or disease||Intervention/treatment||Phase|
|Flail Chest Ventilation||Procedure: operative fixation of fractured ribs||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomised Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||March 2012|
Active Comparator: ORIF
open reduction internal fixation of fractured ribs in flail chest patients
Procedure: operative fixation of fractured ribs
ORIFof fractured ribs in flail chest patients
No Intervention: conservative management
current standard conservative management
- Mechanical ventilation hours [ Time Frame: open ]
- intensive care stay hours [ Time Frame: open ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298259
|The Alfred Hospital|
|Melbourne, Victoria, Australia, 3181|
|Principal Investigator:||Silvana Marasco, FRACS||The Alfred|