Effects of Obesity on Care and Outcomes in Mechanically Ventilated Individuals in the Intensive Care Unit
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|ClinicalTrials.gov Identifier: NCT00296088|
Recruitment Status : Terminated (PI left institution)
First Posted : February 24, 2006
Last Update Posted : July 30, 2013
|Condition or disease|
|Obesity Respiratory Insufficiency|
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.
|Study Type :||Observational|
|Actual Enrollment :||582 participants|
|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|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|