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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02487264
Other study ID # 1125
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2013
Est. completion date December 14, 2017

Study information

Verified date June 2018
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 921
Est. completion date December 14, 2017
Est. primary completion date October 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- must have above and be notated in our medical record

Exclusion Criteria:

- missing data

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Types and treatment of Rib Fractures 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 sequelae and complications from rib fractures sequelae and complications in patients presenting with rib fractures: •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
Past 4 years
Secondary Pain levels Past 4 years
Secondary Patient Characteristics 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
past 4 years
Secondary Current patient quality of life as assessed by telephone survey 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
past 4 years
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