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Completed

NCT Number: NCT00298259

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Alfred Hospital

Melbourne, Victoria, 3181, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

operative fixation of fractured ribs

Procedure

ORIFof fractured ribs in flail chest patients

Primary outcomes

  1. Mechanical ventilation hours

    Time frame: open

  2. intensive care stay hours

    Time frame: open

Sponsors and collaborators

Lead sponsor

The Alfred

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 2, 2006
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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