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

NCT ID: NCT00298259

Last Updated: 2012-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-03-31

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.

Conditions

Flail Chest; Ventilation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ORIF

open reduction internal fixation of fractured ribs in flail chest patients

Group Type: ACTIVE_COMPARATOR

operative fixation of fractured ribs

Intervention Type: PROCEDURE

ORIFof fractured ribs in flail chest patients

conservative management

current standard conservative management

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

operative fixation of fractured ribs

ORIFof fractured ribs in flail chest patients

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Alfred

OTHER

Sponsor Role: lead

Responsible Party

Silvana Marasco

Associate Professor Silvana Marasco

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvana Marasco, FRACS

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Locations

The Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

50/06

Identifier Type: -

Identifier Source: org_study_id