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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomised Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest

Conditions
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Flail Chest, Ventilation

Intervention / Treatment
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* Procedure: operative fixation of fractured ribs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ORIF<br>open reduction internal fixation of fractured ribs in flail chest patients | Procedure: operative fixation of fractured ribs<br>* ORIFof fractured ribs in flail chest patients<br>|
| No Intervention: conservative management<br>current standard conservative management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation hours |  | open | 
| intensive care stay hours |  | open |