ObesityNCT00296088
Effects of Obesity on Care and Outcomes in Mechanically Ventilated Individuals in the Intensive Care Unit
An observational study of Obesity and Respiratory Insufficiency, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Respiratory Insufficiency
- How many people
- 582 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients requiring mechanical ventilation admitted to the OSUMC MICU
Who may be able to join
- Residing in the ICU at Ohio State University Medical Center (OSUMC)
- Receiving mechanical ventilation through an endotracheal tube
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
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
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).
Read the 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.
- Conditions
- Obesity, Respiratory Insufficiency
- Keywords
- Mechanical Ventilation, Critical Care, Respiratory Failure
- Medical subject headings
- Obesity, Respiratory Insufficiency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 582 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- James M. O'Brien, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296088
- Sponsor's protocol ID
- 1330
- Other IDs
- K23HL075076, K23HL075076-01A2
- Status last verified
- Jul 2013
- First submitted
- 23 Feb 2006
- Last updated
- 30 Jul 2013
- Results posted
- No
Publications
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. doi: 10.1097/CCM.0b013e31823e9a80.
PubMed 22430246
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00296088
- Acronym / sponsor ID
- 1330
- Conditions
- Obesity, Respiratory Insufficiency
- Keywords
- Mechanical Ventilation, Critical Care, Respiratory Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2006
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients requiring mechanical ventilation admitted to the OSUMC MICU
Key inclusion criteria (2 listed)
- Residing in the ICU at Ohio State University Medical Center (OSUMC)
- Receiving mechanical ventilation through an endotracheal tube
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Derived from this study: PubMed 22430246O'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. doi: 10.1097/CCM.0b013e31823e9a80.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James M. O'Brien, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Respiratory Insufficiency, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00296088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.