Delirium in Mechanically Ventilated Patients
This study has been completed.
Sponsor:
University of Chicago
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00919698
First received: June 10, 2009
Last updated: December 2, 2014
Last verified: December 2014
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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 ]
| Enrollment: | 102 |
| Study Start Date: | June 2010 |
| Study Completion Date: | October 2013 |
| Primary Completion Date: | October 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919698
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919698
Locations
| United States, Illinois | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
Sponsors and Collaborators
University of Chicago
Investigators
| Principal Investigator: | John P Kress, MD | University of Chicago |
More Information
No publications provided by University of Chicago
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00919698 History of Changes |
| Other Study ID Numbers: | 16938B |
| Study First Received: | June 10, 2009 |
| Last Updated: | December 2, 2014 |
| 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 Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on February 27, 2015