ABC Trial: Awakening and Breathing Controlled

December 9, 2009 updated by: National Institute on Aging (NIA)

Cognitive Impairment in the ICU: Evaluation and Outcomes

The purpose of this study is to determine the impact of a new RN/RRT (Registered Nurse/Registered Respiratory Therapist) directed 2-step protocol to wean patients off of a ventilator. This protocol involves daily attempts to halt sedation (spontaneous awakening trials) combined with daily assessments of patients while they are breathing on their own (spontaneous breathing trials).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Unnecessary delays in removing patients from mechanical ventilation increase morbidity, mortality, and cost. According to recently published guidelines, the current standard of care for weaning involves the daily assessment of patients while they are breathing spontaneously, also known as spontaneous breathing trials (SBT). While there are important data to support a daily cessation of sedatives and analgesics to the point of patient awakening, the benefit of combining such a daily spontaneous awakening trial (SAT) and an SBT is not known.

This multi-center, randomized controlled trial will test whether a 2-step process of weaning that combines a daily awakening trial (achieved by stopping all sedatives and narcotics every morning) with a daily spontaneous breathing trial is superior to the current standard of care.

The number of days the patient is able to live off the ventilator is the primary question being studied. The secondary questions include the number of days the patient is in Intensive Care Unit (ICU) and the hospital, the complications associated with being on the ventilator (such as the duration and severity of delirium and coma), and in-hospital and one-year mortality. Also, cognitive, psychological, and functional/quality of life outcomes will be measured at discharge and 3 and 12 months later.

In addition, the study will measure plasma drug levels twice daily on five sequential days within 30 minutes of testing with highly reliable and well validated instruments to measure sedation level (i.e., RASS) and delirium (i.e. CAM-ICU).

Study Type

Interventional

Enrollment

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania - Presbyterian Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37202
        • St. Thomas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recently on mechanical ventilation (less than 2 weeks prior to enrollment)
  • Require mechanical ventilation for more than 12 hours
  • Over 18 years old
  • Under the services of medicine, cardiology, and neurology

Exclusion Criteria:

  • Admission after cardiopulmonary arrest
  • Inability to obtain informed consent
  • Existence of an extubation order at the time of the evaluation
  • Dependence upon mechanical ventilation for 2 weeks prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ventilator free days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of stay in the ICU and hospital
28-day and 1-year survival
Duration of coma and delirium
Cognitive function
Time Frame: at discharge, 3 months, and 12 months
at discharge, 3 months, and 12 months
Psychological status
Time Frame: at discharge, 3 months, and 12 months
at discharge, 3 months, and 12 months
Functional status
Time Frame: at discharge, 3 months, and 12 months
at discharge, 3 months, and 12 months
Quality of life
Time Frame: at discharge, 3 months, and 12 months
at discharge, 3 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Collaborators

Vanderbilt University
St. Thomas Foundation, Tennessee

Investigators

  • Principal Investigator: E Wesley Ely, MD, MPH, Vanderbilt University Medical Center
  • Study Director: Brenda T Pun, RN, ACNP, Vanderbilt University Medical Center
  • Principal Investigator: Richard W Light, MD, St. Thomas Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

November 24, 2004

First Submitted That Met QC Criteria

November 24, 2004

First Posted (Estimate)

November 25, 2004

Study Record Updates

Last Update Posted (Estimate)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 9, 2009

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AG0011
  • 5K23AG001023-04 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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