Delirium in Mechanically Ventilated Patients

Delirium Clinical Trial

Official title:

An Assessment of Delirium in Mechanically Ventilated Patients Undergoing Daily Awakening From Sedation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919698
• Other study ID #: 16938B
• Status: Completed
• Phase: N/A
• First received: June 10, 2009
• Last updated: December 2, 2014
• Start date: June 2010
• Est. completion date: October 2013

Study information

• Verified date: December 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	survival		1 year	No
Other	institution free days		1 year	No
Primary	Delirium		Daily	No
Secondary	ICU admitting diagnosis		At enrollment	No
Secondary	Medications		Daily	No
Secondary	Ventilator free days (or first 28)		At 28 days post-intubation	No
Secondary	ICU complications		Daily	No
Secondary	Days to discharge		At discharge	No
Secondary	Survival		At discharge	No