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
  Purpose

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 Intervention Phase
Flail Chest
Ventilation
Procedure: operative fixation of fractured ribs
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomised Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • Mechanical ventilation hours [ Time Frame: open ] [ Designated as safety issue: No ]
  • intensive care stay hours [ Time Frame: open ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2007
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Silvana Marasco, Associate Professor Silvana Marasco, The Alfred
ClinicalTrials.gov Identifier: NCT00298259     History of Changes
Other Study ID Numbers: 50/06
Study First Received: March 1, 2006
Last Updated: December 9, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on October 23, 2014