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

NCT00298259 | Completed Phase 2

• 1 other identifier: 50/06
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Mechanical ventilation hours

  open

• intensive care stay hours

  open

Study Arms (2)

ORIF

ACTIVE COMPARATOR

open reduction internal fixation of fractured ribs in flail chest patients

Procedure: operative fixation of fractured ribs

conservative management

NO INTERVENTION

current standard conservative management

Interventions

operative fixation of fractured ribs PROCEDURE

ORIFof fractured ribs in flail chest patients

ORIF

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with multiple (\>3) fractured ribs between the level of ribs 3 to 10 resulting in a paradoxical movement of the chest wall -

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3181, Australia

Location

MeSH Terms

Conditions

Flail Chest; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Thoracic Injuries; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Silvana Marasco, FRACS

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Silvana Marasco

Study Record Dates

• First Submitted: March 1, 2006
• First Posted: March 2, 2006
• Study Start: January 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

AU (1)