Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296088
Status:
TERMINATED
Last Update Posted:
2013-07-30
First Post:
2006-02-23
Brief Title:
Effects of Obesity on Care and Outcomes in Mechanically Ventilated Individuals in the Intensive Care Unit
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23HL075076-01A2 | NIH | None | httpsreporternihgovquickSearchK23HL075076-01A2 |
| K23HL075076 | NIH | None | None |