Analysis of the Status, Treatment and Outcomes of Rib Fractures

• ClinicalTrials.gov Identifier: NCT02487264
• Recruitment Status: Completed
• First Posted: July 1, 2015
• Last Update Posted: June 20, 2018
• Sponsor: Milton S. Hershey Medical Center
• Information provided by (Responsible Party): Julia Caldwell, Milton S. Hershey Medical Center

Study Description

Brief 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.

Condition or disease
Rib Fracture; Trauma

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 Design

• Study Type: Observational
• Actual Enrollment: 921 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Analysis of the Status, Treatment and Outcomes of Rib Fractures
• Actual Study Start Date: June 2013
• Actual Primary Completion Date: October 30, 2016
• Actual Study Completion Date: December 14, 2017

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. Pain levels [ Time Frame: Past 4 years ]
3. 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
4. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

• must have above and be notated in our medical record

Exclusion Criteria:

• missing data

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Julia Caldwell, Assistant Professor of Anesthesiology and Pain Medicine, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT02487264
• Other Study ID Numbers: 1125
• First Posted: July 1, 2015
• Last Update Posted: June 20, 2018
• Last Verified: June 2018

Additional relevant MeSH terms:

Fractures, Bone; Rib Fractures; Wounds and Injuries; Thoracic Injuries