Effects of Obesity on Care and Outcomes in Mechanically Ventilated Individuals in the Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00296088
Recruitment Status : Terminated (PI left institution)
First Posted : February 24, 2006
Last Update Posted : July 30, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ohio State University

Brief Summary:
Obesity is a significant health care issue in the United States, particularly among the critically ill. Preliminary research has shown that differences in ventilator management exist among obese and non-obese individuals. This study will examine the effect of excess weight on ventilator management and clinical outcomes in individuals in an intensive care unit (ICU).

Condition or disease
Obesity Respiratory Insufficiency

Detailed Description:

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
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
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients requiring mechanical ventilation admitted to the OSUMC MICU

Inclusion Criteria:

  • Residing in the ICU at Ohio State University Medical Center (OSUMC)
  • Receiving mechanical ventilation through an endotracheal tube

Exclusion Criteria:

  • Previously enrolled in this study
  • Transferred from another acute care hospital
  • Transferred from another ICU at OSUMC more than 24 hours after admission to that ICU
  • Prisoner
  • Unable to identify a surrogate decision maker or there is a dispute over who is the surrogate decision maker
  • Pregnant
  • Dies prior to study entry

Information from the National Library of Medicine

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 identifier (NCT number): NCT00296088

United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: James M. O'Brien, MD Ohio State University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ohio State University Identifier: NCT00296088     History of Changes
Other Study ID Numbers: 1330
K23HL075076 ( U.S. NIH Grant/Contract )
K23HL075076-01A2 ( U.S. NIH Grant/Contract )
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by Ohio State University:
Mechanical Ventilation
Critical Care
Respiratory Failure

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Nutrition Disorders
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases