Obesity in G60 Trauma Patients / Obesity in G60 Trauma Patients

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT04640701
Collaborator
(none)
100
1
69.6
1.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Obesity in G60 Trauma Patients / Obesity in G60 Trauma Patients
    Actual Study Start Date :
    Jul 12, 2016
    Anticipated Primary Completion Date :
    May 1, 2022
    Anticipated Study Completion Date :
    May 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Obesity's effect on the outcomes of geriatric trauma patients [January1st 2006 and June 30th 2016]

      Type of Injury (length of stay)

    Secondary Outcome Measures

    1. Body mass index [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.

    2. Length of stay [January1st 2006 and June 30th 2016]

      measured in days

    3. Injury severity score [January1st 2006 and June 30th 2016]

      Injury severity score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Dallas Medical Center Dallas Texas United States 75203

    Sponsors and Collaborators

    • Methodist Health System

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Methodist Health System
    ClinicalTrials.gov Identifier:
    NCT04640701
    Other Study ID Numbers:
    • 046.TRA.2016.D
    First Posted:
    Nov 23, 2020
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2022