Analysis of the Status, Treatment and Outcomes of Rib Fractures

June 19, 2018 updated by: Julia Caldwell, Milton S. Hershey Medical Center
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.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a retrospective chart review with follow-up phone calls.

The initial part of the study will be a retrospective chart review. For this chart review study, the following data elements will be entered for each participant.

The investigators will perform a retrospective study of patients who have been treated for rib fractures at Penn State Hershey Medical Center (PSHMC). The time period of review will be 1/10/10 - 1/10/12 until 1500 cases have been reviewed. Data collected will be:

  • Patient Medical Record Number (MRN)
  • Name
  • Phone number
  • length of stay (admit and discharge date)
  • Number of rib fractures per patient
  • Cause of rib fracture
  • 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
  • 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
  • Sequelae of rib fracture, including:

    1. Acute Respiratory Deficiency Syndrome (ARDS)
    2. Pneumonia
    3. Death
    4. chronic pain
    5. delayed subclavian vessel thrombosis
    6. aortic aneurysm
    7. tracheobronchial fistula
    8. thoracic outlet syndrome
    9. Horner's syndrome
  • 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

7.2.2 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

Study Type

Observational

Enrollment (Actual)

921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients presenting during 2010-2012 with multiple rib fractures to PSHMC emergency department

Description

Inclusion Criteria:

  • must have above and be notated in our medical record

Exclusion Criteria:

  • missing data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Past 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Past 4 years
Pain levels
Time Frame: Past 4 years
Past 4 years
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
past 4 years
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
past 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

October 30, 2016

Study Completion (Actual)

December 14, 2017

Study Registration Dates

First Submitted

April 5, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 1125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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