Delirium in Mechanically Ventilated Patients
This study is currently recruiting participants.
Verified January 2013 by University of Chicago
Sponsor:
University of Chicago
Information provided by (Responsible Party):
John Kress, University of Chicago
ClinicalTrials.gov Identifier:
NCT00919698
First received: June 10, 2009
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.
| Condition |
|---|
|
Delirium |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | An Assessment of Delirium in Mechanically Ventilated Patients Undergoing Daily Awakening From Sedation |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Delirium [ Time Frame: Daily ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- ICU admitting diagnosis [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
- Medications [ Time Frame: Daily ] [ Designated as safety issue: No ]
- Ventilator free days (or first 28) [ Time Frame: At 28 days post-intubation ] [ Designated as safety issue: No ]
- ICU complications [ Time Frame: Daily ] [ Designated as safety issue: No ]
- Days to discharge [ Time Frame: At discharge ] [ Designated as safety issue: No ]
- Survival [ Time Frame: At discharge ] [ Designated as safety issue: No ]
Other Outcome Measures:
- survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- institution free days [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Sedated mechanically ventilated patients |
Detailed Description:
This is a single center, observational, cross-over design study assessing the impact of daily awakening from sedation on delirium in the ICU. Enrolled patients will receive a daily baseline delirium assessment using the CAM-ICU tool before the awakening from sedation and an assessment during the awakening from sedation. Each patient will thus serve as their own controls for these interventions.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Adult patients (> 18 years old) admitted to the intensive care unit who require mechanical ventilation through an endotracheal tube with infusion of sedative or analgesic medication.
Criteria
Inclusion Criteria:
- > 18 years old
- intubated and mechanically ventilated
- receiving sedative and/or analgesic medication
- candidate for daily awakening from sedative and/or analgesic medication
Exclusion Criteria:
- primary neurologic disease (stroke, seizure, elevated ICP)
- post cardiac arrest
- do not speak English (assessment only English language validated)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919698
Contacts
| Contact: John P Kress, MD | 773-702-6404 | jkress@medicine.bsd.uchicago.edu |
| Contact: Anne S Pohlman, RN | 773-702-3804 | apohlman@medicince.bsd.uchicago.edu |
Locations
| United States, Illinois | |
| The University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: John P Kress, MD 773-702-6404 jkress@medicine.bsd.uchicago.edu | |
Sponsors and Collaborators
University of Chicago
Investigators
| Principal Investigator: | John P Kress, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | John Kress, Asst Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00919698 History of Changes |
| Other Study ID Numbers: | 16938B |
| Study First Received: | June 10, 2009 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Hypnotics and Sedatives Respiration, Artificial Ventilators, Mechanical Critical care Intensive care |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013