Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Silvana Marasco, The Alfred
ClinicalTrials.gov Identifier:
NCT00298259
First received: March 1, 2006
Last updated: December 9, 2012
Last verified: December 2012

March 1, 2006
December 9, 2012
January 2007
January 2012   (final data collection date for primary outcome measure)
  • Mechanical ventilation hours [ Time Frame: open ] [ Designated as safety issue: No ]
  • intensive care stay hours [ Time Frame: open ] [ Designated as safety issue: No ]
  • Mechanical ventilation hours
  • intensive care stay hours
Complete list of historical versions of study NCT00298259 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
Prospective Randomised Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Flail Chest
  • Ventilation
Procedure: operative fixation of fractured ribs
ORIFof fractured ribs in flail chest patients
  • Active Comparator: ORIF
    open reduction internal fixation of fractured ribs in flail chest patients
    Intervention: Procedure: operative fixation of fractured ribs
  • No Intervention: conservative management
    current standard conservative management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
March 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with multiple (>3) fractured ribs between the level of ribs 3 to 10 resulting in a paradoxical movement of the chest wall -

Exclusion Criteria:

  • age > 75 years
  • Spinal injuries which would preclude placement of the patient in a lateral decubitus position
  • Open rib fractures with soiling or infection
  • Severe head injury
  • Uncorrected coagulopathy
  • Adult respiratory distress syndrome
  • Sepsis
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00298259
50/06
No
Silvana Marasco, The Alfred
The Alfred
Not Provided
Principal Investigator: Silvana Marasco, FRACS The Alfred
The Alfred
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP