Analysis of the Status, Treatment and Outcomes of Rib Fractures

Trauma Clinical Trial

Official title:

Analysis of the Status, Treatment and Outcomes of Rib Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487264
• Other study ID #: 1125
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Rib Fracture
• Rib Fractures
• Trauma

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