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

Phase 2

Completed

• Conditions: Flail Chest; Ventilation
• Interventions: Procedure: operative fixation of fractured ribs

• Registration Number: NCT00298259
• Lead Sponsor: The Alfred

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-01
• Study First Submitted QC: 2006-03-01
• Study First Posted: 2006-03-02
• Study Start: 2007-01
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-09
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORIF	operative fixation of fractured ribs	open reduction internal fixation of fractured ribs in flail chest patients

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation hours	open
intensive care stay hours	open

Trial Locations

Locations (1)

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia