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

Primary Purpose

Flail Chest, Ventilation

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
operative fixation of fractured ribs
Sponsored by
The Alfred
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flail Chest

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Alfred Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ORIF

conservative management

Arm Description

open reduction internal fixation of fractured ribs in flail chest patients

current standard conservative management

Outcomes

Primary Outcome Measures

Mechanical ventilation hours
intensive care stay hours

Secondary Outcome Measures

Full Information

First Posted
March 1, 2006
Last Updated
December 9, 2012
Sponsor
The Alfred
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1. Study Identification

Unique Protocol Identification Number
NCT00298259
Brief Title
Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
Official Title
Prospective Randomised Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Alfred

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flail Chest, Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORIF
Arm Type
Active Comparator
Arm Description
open reduction internal fixation of fractured ribs in flail chest patients
Arm Title
conservative management
Arm Type
No Intervention
Arm Description
current standard conservative management
Intervention Type
Procedure
Intervention Name(s)
operative fixation of fractured ribs
Intervention Description
ORIFof fractured ribs in flail chest patients
Primary Outcome Measure Information:
Title
Mechanical ventilation hours
Time Frame
open
Title
intensive care stay hours
Time Frame
open

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvana Marasco, FRACS
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia

12. IPD Sharing Statement

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

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