- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02487264
Analysis of the Status, Treatment and Outcomes of Rib Fractures
Study Overview
Status
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:
- Shortness of Breath (SOB)
- Hemothorax,
- Pneumothorax
- Flail chest
- Intubation required
- Mechanical ventilation required
- Opioids required for pain
- Chest tube placement required
Sequelae of rib fracture, including:
- Acute Respiratory Deficiency Syndrome (ARDS)
- Pneumonia
- Death
- chronic pain
- delayed subclavian vessel thrombosis
- aortic aneurysm
- tracheobronchial fistula
- thoracic outlet syndrome
- Horner's syndrome
Clinical history of
- Rib fractures
- Other fractures
- Osteoporosis
- Chronic Obstructive Pulmonary Disease (COPD)
- Cancer
- Myocardial Infarction (MI) / Coronary Artery Disease (CAD)
- Arthritis
- Parkinson's disease
Patient characteristics:
- Age
- Gender
- Race
- Body Mass Index (BMI)
- Alcohol use
- Smoking status
- Marital status
- Education
- 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:
- pain score
- quality of life via the EuroQol's quality of life survey :EQ-5D-3L questionnaire
- pain meds
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- must have above and be notated in our medical record
Exclusion Criteria:
- missing data
Study Plan
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
|
|
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:
|
Past 4 years
|
Pain levels
Time Frame: Past 4 years
|
Past 4 years
|
|
Patient Characteristics
Time Frame: past 4 years
|
|
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:
|
past 4 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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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