Delirium in Mechanically Ventilated Patients

NCT ID: NCT00919698

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sedated mechanically ventilated patients

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John P Kress, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Patel SB, Poston JT, Pohlman A, Hall JB, Kress JP. Rapidly reversible, sedation-related delirium versus persistent delirium in the intensive care unit. Am J Respir Crit Care Med. 2014 Mar 15;189(6):658-65. doi: 10.1164/rccm.201310-1815OC.

Reference Type DERIVED
PMID: 24423152 (View on PubMed)

Other Identifiers

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16938B

Identifier Type: -

Identifier Source: org_study_id