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Analysis of the Status, Treatment and Outcomes of Rib Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02487264
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Julia Caldwell, Milton S. Hershey Medical Center

Brief Summary:
A retrospective analysis of all patient presenting with multiple rib fractures to the emergency room of Penn State Hershey Medical Center between 2010-2012. Patient demographics, cause of fracture, outcomes, chronic medical conditions, vital signs, length of stay, pain levels and treatment, and sequelae will be recorded and analyzed.

Condition or disease
Rib Fracture Trauma

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Study Type : Observational
Actual Enrollment : 921 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Analysis of the Status, Treatment and Outcomes of Rib Fractures
Actual Study Start Date : June 2013
Actual Primary Completion Date : October 30, 2016
Actual Study Completion Date : December 14, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Types and treatment of Rib Fractures [ Time Frame: Past 4 years ]
    • Characteristics of the fracture (unilateral versus bilateral and multiple versus single)
    • Pain management used for the rib fracture including pain interventions, medications and all pain scores


Secondary Outcome Measures :
  1. sequelae and complications from rib fractures [ Time Frame: Past 4 years ]

    sequelae and complications in patients presenting with rib fractures: •Complications attributable to the rib fracture, including:

    1. Shortness of Breath (SOB)
    2. Hemothorax,
    3. Pneumothorax
    4. Flail chest
    5. Intubation required
    6. Mechanical ventilation required
    7. Opioids required for pain
    8. Chest tube placement required

  2. Pain levels [ Time Frame: Past 4 years ]
  3. Patient Characteristics [ Time Frame: past 4 years ]
    • Clinical history of

      1. Rib fractures
      2. Other fractures
      3. Osteoporosis
      4. Chronic Obstructive Pulmonary Disease (COPD)
      5. Cancer
      6. Myocardial Infarction (MI) / Coronary Artery Disease (CAD)
      7. Arthritis
      8. Parkinson's disease
    • Patient characteristics:

      1. Age
      2. Gender
      3. Race
      4. Body Mass Index (BMI)
      5. Alcohol use
      6. Smoking status
      7. Marital status
      8. Education
      9. Initial blood pressure

  4. Current patient quality of life as assessed by telephone survey [ Time Frame: past 4 years ]

    Follow-up phone calls

    The investigators will then attempt to call the patients for follow-up information using a summary explanation of research phone script to obtain the following information:

    1. pain score
    2. quality of life via the EuroQol's quality of life survey :EQ-5D-3L questionnaire
    3. pain meds



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients presenting during 2010-2012 with multiple rib fractures to PSHMC emergency department
Criteria

Inclusion Criteria:

  • must have above and be notated in our medical record

Exclusion Criteria:

  • missing data
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Responsible Party: Julia Caldwell, Assistant Professor of Anesthesiology and Pain Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02487264    
Other Study ID Numbers: 1125
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Wounds and Injuries
Thoracic Injuries