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

This study has been terminated.
(PI left institution)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ohio State University
ClinicalTrials.gov Identifier:
NCT00296088
First received: February 23, 2006
Last updated: July 29, 2013
Last verified: July 2013

February 23, 2006
July 29, 2013
February 2006
April 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00296088 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Obesity on Care and Outcomes in Mechanically Ventilated Individuals in the Intensive Care Unit
A Prospective Observational Study of the Association Between Excess Body Weight and Outcome and Process Measures in Mechanically Ventilated Medical Intensive Care Unit Patients

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

patients requiring mechanical ventilation admitted to the OSUMC MICU

  • Obesity
  • Respiratory Insufficiency
Not Provided
Not Provided
O'Brien JM Jr, Philips GS, Ali NA, Aberegg SK, Marsh CB, Lemeshow S. The association between body mass index, processes of care, and outcomes from mechanical ventilation: a prospective cohort study. Crit Care Med. 2012 May;40(5):1456-63.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
582
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00296088
1330, K23HL075076, K23 HL075076-01A2
Not Provided
Ohio State University
Ohio State University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: James M. O'Brien, MD Ohio State University
Ohio State University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP