Effects of Obesity on Care and Outcomes in Mechanically Ventilated Individuals in the Intensive Care Unit
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Observational Study of the Association Between Excess Body Weight and Outcome and Process Measures in Mechanically Ventilated Medical Intensive Care Unit Patients|
|Study Start Date:||February 2006|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Sixty-four percent of American adults are overweight or obese. Excess weight will soon surpass smoking as the most common cause of preventable death. Despite the well-known health consequences of obesity, little is known about the specific effects of obesity in critically ill individuals. There are significant differences in ventilator management procedures among obese and non-obese individuals in an ICU. The long-term effect of these differences, however, has not been studied. Preliminary research has shown that differences in the mechanical ventilation process may be responsible for worse outcomes in obese individuals, as compared to non-obese individuals. The purpose of this study is to examine the effect of obesity on ventilator management processes and medical outcomes in individuals in an ICU. The study will also identify any increased risks for the critically ill obese and the causes of their augmented mortality and morbidity levels.
This study will enroll individuals in an ICU who are receiving mechanical ventilation through an endotracheal tube. Because potential participants are critically ill, and are unable to provide consent to participate in the study, each participant must have a surrogate decision maker who will provide consent on their behalf. Once enrolled, participants' weight, height, and waist circumference will be measured. Medical outcomes and information on the processes of ventilator management and care will be assessed while participants are in the ICU. Information on hospital outcomes, quality of life, utility, employment, and living situation will be collected upon release from the ICU, as well as during follow-up telephone interviews, which will occur every 90 days for a period of up to two years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296088
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||James M. O'Brien, MD||Ohio State University|