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NCT01413009 · ClinicalTrials.gov registry record

Awakening-Breathing Coordination, Delirium Monitoring/Management & Early Mobility (ABCDE) Protocol

A clinical trial of ICU Delirium and Immobility, sponsored by University of Nebraska.

Completed
Registry status
200
Enrollment target
1
Study location

NCT01413009: Completed study of ICU Delirium and Immobility, sponsored by University of Nebraska.

NCT01413009 is a study of ICU Delirium and Immobility that has completed, run by University of Nebraska. The registered enrollment target is 200 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01413009, a study of ICU Delirium and Immobility, has completed, sponsored by University of Nebraska.

COMPLETED
Registry status
200 participants
Enrollment target
1
Study location

Study Summary

Fully two-thirds of ICU patients develop delirium, which is associated with longer stays, billions of dollars in costs globally, and 3-fold excess mortality at 6 months. Over one-half of ICU survivors suffer a functionally debilitating dementia-like illness, which appears related to delirium duration. This study will focus on applying Awakening-Breathing Coordination, Delirium Monitoring/Management \& Early Mobility (ABCDE), a program of delirium screening, prevention, and treatment developed at Vanderbilt University. Specifically, the study will implement the ABCDE program in a medical center that does not currently perform routine ICU delirium screenings and identify facilitators and barriers to program adoption; test the impact of the ABCDE program on patient outcomes, nursing quality outcomes, and system outcomes; and assess the extent to which ABCDE implementation is effective, sustainable, and conducive to dissemination into other settings.

Primary Outcome

The primary outcome will be a comparison between the 3 month baseline period of ventilator free days and the 9 month period following the intervention. Two interim analyses will be conducted.

Conditions Studied

Study Locations (1)

Nebraska

  • University of Nebraska Medical Center - Omaha

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2010-12-29
Est. Completion 2013-06-01
University of Nebraska

407 total trials

What the finished NCT01413009 record still lists

NCT01413009 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.

The record links to 2 conditions, with ICU Delirium appearing as the primary indexed condition, and to 0 interventions.

NCT01413009 reports a single indexed study location in Nebraska.

Frequently Asked Questions

What is clinical trial NCT01413009 about?

NCT01413009 is a clinical study titled "Awakening-Breathing Coordination, Delirium Monitoring/Management & Early Mobility (ABCDE) Protocol". Fully two-thirds of ICU patients develop delirium, which is associated with longer stays, billions of dollars in costs globally, and 3-fold excess mortality at 6 months. Over one-half of ICU survivors suffer a functionally debilitating dementia-like illness, which appears related to delirium duratio...

What is the current status of trial NCT01413009?

This trial is currently completed. The enrollment target is 200 participants. The study started on 2010-12-29. Estimated completion is 2013-06-01.

What conditions does trial NCT01413009 study?

This clinical trial studies the following conditions: ICU Delirium, Immobility.

Who is sponsoring clinical trial NCT01413009?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01413009 being conducted?

This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01413009, the US trial registry maintained by the National Library of Medicine. NCT01413009 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.