Obesity in G60 Trauma Patients / Obesity in G60 Trauma Patients (Obesity)

August 9, 2023 updated by: Methodist Health System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75203
        • Methodist Dallas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Records of trauma patients who were admitted to MHS between January1st 2006 and June 30th 2016

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obesity's effect on the outcomes of geriatric trauma patients
Time Frame: January1st 2006 and June 30th 2016
Type of Injury (length of stay)
January1st 2006 and June 30th 2016

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body mass index
Time Frame: January1st 2006 and June 30th 2016
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
Length of stay
Time Frame: January1st 2006 and June 30th 2016
measured in days
January1st 2006 and June 30th 2016
Injury severity score
Time Frame: January1st 2006 and June 30th 2016
Injury severity score
January1st 2006 and June 30th 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael Truitt, M.D., Methodist Dallas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2016

Primary Completion (Actual)

May 13, 2022

Study Completion (Actual)

May 13, 2022

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

November 18, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 046.TRA.2016.D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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