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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Milton S. Hershey Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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