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Completed

NCT Number: NCT00919698

Delirium in Mechanically Ventilated Patients

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.

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Key information

Conditions

Delirium Confusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Delirium

    Time frame: Daily

Secondary outcomes

  1. ICU admitting diagnosis

    Time frame: At enrollment

  2. Medications

    Time frame: Daily

  3. Ventilator free days (or first 28)

    Time frame: At 28 days post-intubation

  4. ICU complications

    Time frame: Daily

  5. Days to discharge

    Time frame: At discharge

  6. Survival

    Time frame: At discharge

Other outcomes

  1. survival

    Time frame: 1 year

  2. institution free days

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 12, 2009
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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