Delirium in Mechanically Ventilated Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00919698
First received: June 10, 2009
Last updated: March 12, 2014
Last verified: March 2014
  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 2014
Estimated Primary Completion Date: November 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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 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: March 12, 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
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014