Obesity in G60 Trauma Patients / Obesity in G60 Trauma Patients

Obesity Clinical Trial

— Obesity  

Official title:

Obesity in G60 Trauma Patients / Obesity in G60 Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640701
• Other study ID #: 046.TRA.2016.D
• Status: Completed
• Start date: July 12, 2016
• Est. completion date: May 13, 2022

Study information

• Verified date: August 2023
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Obesity is a national epidemic that affects all aspects of health care, including trauma care. According to the Centers for Disease Control and Prevention, 1% of US adults 20 years old and older are obese (body mass index [BMI], calculated as weight in kilograms divided by height in meters squared, > 30), and 69% are overweight (BMI > 25) (1, 2). Obesity is a major health concern because of its established relationship with serious medical diseases and increased likelihood of comorbid conditions (eg, diabetes mellitus, hyperlipidemia, heart disease, pulmonary disease) (3). As the number of obese adults continues to increase, the potential number of obese trauma patients with severe injury and complications will also increase (3). Management of prehospital and in-hospital trauma care, including complications associated with airway management, surgical procedures, and radiological imaging, of obese patients can be challenging. However, published reports on how obesity complicates hospital stays after trauma are conflicting (4, 5). Several studies have indicated that obese trauma patients are more likely than non-obese patients to have longer stays in the intensive care unit (ICU) and hospital, more days of mechanical ventilation, more complications, and comorbid conditions, and higher mortality (6,7,8). Other studies have indicated no differences between obese and nonobese patients in mortality, length of stay in the ICU and the hospital, duration of mechanical ventilation, complications, or comorbid conditions (9). Accordingly, the main aim of this study is to investigate and compare hospital course, clinical outcomes, disposition, and the cost of treatment between geriatric obese and non-obese patients hospitalized for treatment of traumatic injuries.

Description:

This proposed research is a retrospective chart review to determine if trauma patients with different body mass indexes differed in hospital course, clinical outcomes, disposition, and the cost of treatment.

Records of trauma patients who were admitted to MHS between January1st 2006 and June 30th 2016 will be retrieved to review the clinical charts according to the investigator's inclusion and exclusion criteria.

Basic demographics and clinical outcomes parameters as noted above will be attained from the patient's medical records.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 13, 2022
• Est. primary completion date: May 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Male and female patient's = 60 years of age.

2. Blunt and penetration injury.

Exclusion Criteria:

1. Pregnant and breastfeeding women.

2. Patients < 60 years of age

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obesity's effect on the outcomes of geriatric trauma patients	Type of Injury (length of stay)	January1st 2006 and June 30th 2016
Secondary	Body mass index	Body mass index is calculated as weight in kilograms divided by height in meters squared, > 30). Weight (Kgs) & hight (cms) measured from subjects are combined to report BMI.	January1st 2006 and June 30th 2016
Secondary	Length of stay	measured in days	January1st 2006 and June 30th 2016
Secondary	Injury severity score	Injury severity score	January1st 2006 and June 30th 2016