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.

Study Overview

• Status: Completed
• Conditions: Ventilation; Flail Chest
• Intervention / Treatment: Procedure: operative fixation of fractured ribs

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3181
      • The Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mechanical ventilation hours	open
intensive care stay hours	open

Collaborators and Investigators

• Sponsor: The Alfred
• Investigators: Principal Investigator: Silvana Marasco, FRACS, The Alfred

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 1, 2006
• First Submitted That Met QC Criteria: March 1, 2006
• First Posted (Estimate): March 2, 2006

Study Record Updates

• Last Update Posted (Estimate): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 9, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Flail Chest
• Other Study ID Numbers: 50/06