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

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ClinicalTrials.gov Identifier: NCT00298259
Recruitment Status : Completed
First Posted : March 2, 2006
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomised Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
Study Start Date : January 2007
Primary Completion Date : January 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Mechanical ventilation hours [ Time Frame: open ]
  2. intensive care stay hours [ Time Frame: open ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
The Alfred
Investigators
Principal Investigator: Silvana Marasco, FRACS The Alfred
More Information

Responsible Party: Silvana Marasco, Associate Professor Silvana Marasco, The Alfred
ClinicalTrials.gov Identifier: NCT00298259     History of Changes
Other Study ID Numbers: 50/06
First Posted: March 2, 2006    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Flail Chest
Rib Fractures
Thoracic Injuries
Wounds and Injuries
Fractures, Bone